510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K905689Substantially Equivalent

Cedia Phenytoin Assay

Microgenics Corporation, Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905689 is the FDA 510(k) clearance record for CEDIA PHENYTOIN ASSAY, a class II device, cleared for Microgenics Corp. on under FDA product code DIP (Enzyme Immunoassay, Diphenylhydantoin). FDA records list 128 510(k) clearances for Microgenics Corp., from to . As of , FDA records show no recalls naming K905689.

Clearance record

Decision date
Received
(29 days to decision)
Product code
DIP Enzyme Immunoassay, Diphenylhydantoin
Regulation
21 CFR 862.3350
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Microgenics Corp. 2380a Bisso Ln., Concord CA
Third party review
No

Clearances, product code DIP

Trailing 12 months

FDA records hold no clearances under product code DIP in the trailing twelve months.

FDA records show no clearances under product code DIP in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DIP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260