510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963840Substantially Equivalent

Cedia Phenytoin II Assay

Boehringer Mannheim Corp., Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963840 is the FDA 510(k) clearance record for CEDIA PHENYTOIN II ASSAY, a class II device, cleared for Boehringer Mannheim Corp. on under FDA product code DIP (Enzyme Immunoassay, Diphenylhydantoin). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K963840.

Clearance record

Decision date
Received
(57 days to decision)
Product code
DIP Enzyme Immunoassay, Diphenylhydantoin
Regulation
21 CFR 862.3350
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Boehringer Mannheim Corp. 2400 Bisso Ln., Concord CA
510(k) summary
Summary
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DIP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260