FDA applicant

Syva / A Syntex Co.

Palo Alto, CA2 decisions1986–19860 recalls

FDA records 2 decisions for Syva / A Syntex Co. (Palo Alto, CA) in 1986: 2 510(k) clearances. Most are in product codes DIP (Enzyme Immunoassay, Diphenylhydantoin) and LAS (Drug Specific Control Materials). No recall is 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 / A Syntex Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Syva / A Syntex Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Syva”

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

Syva Co. 448 Syva Co., Dade Behring, Inc. 19

Syva / A Syntex Co.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Syva”