510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K920005Substantially Equivalent

Il Test Alpha-1-Antitrypsin (Aat)

Instrumentation Laboratory Co., Lexington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920005 is the FDA 510(k) clearance record for IL TEST ALPHA-1-ANTITRYPSIN (AAT), a class II device, cleared for Instrumentation Laboratory CO on under FDA product code DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control). FDA records list 327 510(k) clearances for Instrumentation Laboratory CO, from to . As of , FDA records show no recalls naming K920005.

Clearance record

Decision date
Received
(209 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
Instrumentation Laboratory CO 113 Hartwell Ave., Lexington MA
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DEM, 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