510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972640Substantially Equivalent

Tina-Quant Alpha Particle-1-Antitrypsin Assay

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

K972640 is the FDA 510(k) clearance record for TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY, a class II device, cleared for Boehringer Mannheim Corp. on under FDA product code DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K972640.

Clearance record

Decision date
Received
(178 days to decision)
Product code
DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5130
Device class
Class II
Review panel
Immunology
Applicant
Boehringer Mannheim Corp. 2380a Bisso Ln., Concord CA
510(k) summary
Summary
Third party review
No

Clearances, product code DEM

Trailing 12 months

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

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