510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K954608Substantially Equivalent

Cedia Dau Multi-Dr Calibrator/pri, Sec, Inter, High

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

K954608 is the FDA 510(k) clearance record for CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH, a class II device, cleared for Boehringer Mannheim Corp. on under FDA product code DKB (Calibrators, Drug Mixture). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K954608.

Clearance record

Decision date
Received
(83 days to decision)
Product code
DKB Calibrators, Drug Mixture
Regulation
21 CFR 862.3200
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 DKB

Trailing 12 months

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

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