510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K964368Substantially Equivalent

Elecsys Cea Assay

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

K964368 is the FDA 510(k) clearance record for ELECSYS CEA ASSAY, a class II device, cleared for Boehringer Mannheim Corp. on under FDA product code JIT (Calibrator, Secondary). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K964368.

Clearance record

Decision date
Received
(227 days to decision)
Product code
JIT Calibrator, Secondary
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Boehringer Mannheim Corp. 2400 Bisso Ln., Concord CA
510(k) summary
Summary
Third party review
No

Clearances, product code JIT

Trailing 12 months

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

FDA records show no clearances under product code JIT in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JIT, 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