510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010978Substantially Equivalent

Tina-Quant Alpha-1 Antitrypsin

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

K010978 is the FDA 510(k) clearance record for TINA-QUANT ALPHA-1 ANTITRYPSIN, a class II device, cleared for Rochdiag on under FDA product code DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control). FDA records list 3 510(k) clearances for Rochdiag, from to . As of , FDA records show no recalls naming K010978.

Clearance record

Decision date
Received
(66 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
Rochdiag 9115 Hague Rd., Indianapolis IN
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