510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K955908Substantially Equivalent

Boehringer Mannheim Igm Assay

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

K955908 is the FDA 510(k) clearance record for BOEHRINGER MANNHEIM IGM ASSAY, a class II device, cleared for Boehringer Mannheim Corp. on under FDA product code DAO (Igm (Mu Chain Specific), Antigen, Antiserum, Control). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K955908.

Clearance record

Decision date
Received
(42 days to decision)
Product code
DAO Igm (Mu Chain Specific), Antigen, Antiserum, Control
Regulation
21 CFR 866.5550
Device class
Class II
Review panel
Immunology
Applicant
Boehringer Mannheim Corp. 9115 Hague Rd., P.O. Box 50457, Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code DAO

Trailing 12 months

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

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