510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K772250Substantially Equivalent

Alpha-1-Antitrypsin Nephel. Assay

Kallestad Laboratories, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K772250 is the FDA 510(k) clearance record for ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY, a class II device, cleared for Kallestad Laboratories, Inc. on under FDA product code DEI (Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control). FDA records list 92 510(k) clearances for Kallestad Laboratories, Inc., from to . As of , FDA records show no recalls naming K772250.

Clearance record

Decision date
Received
(13 days to decision)
Product code
DEI Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5130
Device class
Class II
Review panel
Immunology
Applicant
Kallestad Laboratories, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DEI

Trailing 12 months

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

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