510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K965157Substantially Equivalent

Cedia Dau Multi-Drug Control Cedia Dau Specialty Control Set 1

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

K965157 is the FDA 510(k) clearance record for CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1, a class I device, cleared for Boehringer Mannheim Corp. on under FDA product code DIF (Drug Mixture Control Materials). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K965157.

Clearance record

Decision date
Received
(25 days to decision)
Product code
DIF Drug Mixture Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Boehringer Mannheim Corp. 2400 Bisso Ln., Concord CA
510(k) summary
Summary
Third party review
No

Clearances, product code DIF

Trailing 12 months

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

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