510(k) Report

FDA applicant

Syva Co.

Mchenry, IL448 decisions1976–200115 recalls

FDA records 448 decisions for Syva Co. (Mchenry, IL) from 1976 to 2001: 448 510(k) clearances. Most are in product codes LAS (Drug Specific Control Materials) and DKB (Calibrators, Drug Mixture). Its devices cite 7 predicates, 5 of them its own earlier devices. 15 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical toxicology panel, where it files most

How often FDA has decided Syva Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Syva Co. since 2007.

Recalls per year

3in 2026

2008: 12009: 12012: 42013: 12016: 32017: 12026 (partial year): 3
2007high 4 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Syva Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Syva Co.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LASDrug Specific Control Materials22decisions
  • DKBCalibrators, Drug Mixture21decisions
  • DLJCalibrators, Drug Specific18decisions
  • LDJEnzyme Immunoassay, Cannabinoids17decisions
  • KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine14decisions
  • DISEnzyme Immunoassay, Barbiturate13decisions

Also: DIF (13), DKZ (13), JXM (13), KLT (12), KLS (11), DIP (10).

Whose devices does it build on?

Its devices cite 7 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 41 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K881040Emit Vancomycin AssaySyva Co. · 19882cite it
  • K853872Emit Caffeine AssaySyva Co. · 19862cite it
  • K993755Emit Calibrater/Control Level 0, Level 1, Level 2, Level 3, Level 4, Level 5Syva Co. · 19992cite it
  • K993985Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129ULSyva Co. · 20002cite it
  • K993988Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029ULSyva Co. · 20002cite it
  • K880157Microtrak HSV 1/HSV 2 Culture Identi./Typing TestSyva Co. · 19882cite it

What has FDA decided for it lately?

  • K011878Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators, Model 7S109ULSyva Co. · 2001
  • K012257Emit II Plus Monoclonal Amphetamine/Methamphetamine Assay Model OSR9C229Syva Co. · 2001
  • K011947Emit 2000 Valproic Acid Assay, Model OSR4G229ULSyva Co. · 2001
  • K011528Emit 2000 Phenobarbital Assay, Model OSR4D229Syva Co. · 20013 recalls
  • K011347Emit 2000 Phenytoin Assay, Model 0SR4A229Syva Co. · 2001
  • K993980Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULSyva Co. · 2000
  • K993981Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULSyva Co. · 2000
  • K993029Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and 6E89Syva Co. · 2000

All 448 as Syva Co. →

What has been recalled?

15 recalls linked to its devices; the latest:

  • K922913Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mLJul 13, 2026Class II
  • K821743Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog…Jun 26, 2026Class III
  • K801204Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319ULJun 26, 2026Class III
  • K913123Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is…Nov 27, 2017Class II
  • K913123Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme…Jun 17, 2016Class II
  • K913123ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro…Jun 17, 2016Class II

Other applicant names beginning “Syva”

FDA records each applicant name separately; these may or may not be the same firm.

Syva Co., Dade Behring, Inc. 19Syva / A Syntex Co. 2