510(k) Report

510(k) · Cleared

Cleared

Emit (R) 2000 Gentamicin Assay/Calibrators

K913410510(k) TraditionalCleared Sep 16, 199147-day reviewClass II21 CFR 862.3620

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Syva Co. · DMB Gas Chromatography, Methadone

Cleared on Sep 16, 1991 after a 47-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Sep 16, 1991
Review
47 days
Class
Class II
Product code
DMB
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K913410Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All DMB devices

DMB Gas Chromatography, Methadone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DMB

FDA has decided no DMB device since 2007.

Median 510(k) review, days · DMB

Too few DMB 510(k)s in any year since 2007 to give a median.

Recalls per year · DMB

No recall names DMB since 2007.

Adverse event reports per year · DMB

No MAUDE report names DMB since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Syva Co.

448 FDA decisions under this applicant name. See the company

  • 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

https://510kreport.com/device/K913410 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913410: Emit (R) 2000 Gentamicin Assay/Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913410

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026