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
K965100Substantially Equivalent

N-Assay Tia Alpha-1-Antitrypsin Test Kit

Crestat Diagnostics, Inc., Weston CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965100 is the FDA 510(k) clearance record for N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT, a class II device, cleared for Crestat Diagnostics, Inc. on under FDA product code DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control). FDA records list 29 510(k) clearances for Crestat Diagnostics, Inc., from to . As of , FDA records show one recall naming K965100.

Clearance record

Decision date
Received
(206 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
Crestat Diagnostics, Inc. 374 Goodhill Rd., Weston CT
510(k) summary
Statement
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