510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K871027Substantially Equivalent

Precinorm(r) Protein

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

K871027 is the FDA 510(k) clearance record for PRECINORM(R) PROTEIN, a class II device, cleared for Boehringer Mannheim Corp. on under FDA product code DAF (Gamma Globulin, Fitc, Antigen, Antiserum, Control). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K871027.

Clearance record

Decision date
Received
(60 days to decision)
Product code
DAF Gamma Globulin, Fitc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Boehringer Mannheim Corp. 9115 Hague Rd., Indianapolis IN
Third party review
No

Clearances, product code DAF

Trailing 12 months

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

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