510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802284Substantially Equivalent

Antisera to Human Free Lambda Light Ch.

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

K802284 is the FDA 510(k) clearance record for ANTISERA TO HUMAN FREE LAMBDA LIGHT CH., a class II device, cleared for Kallestad Laboratories, Inc. on under FDA product code CZQ (Bence-Jones Protein, Antigen, Antiserum, Control). FDA records list 92 510(k) clearances for Kallestad Laboratories, Inc., from to . As of , FDA records show no recalls naming K802284.

Clearance record

Decision date
Received
(34 days to decision)
Product code
CZQ Bence-Jones Protein, Antigen, Antiserum, Control
Regulation
21 CFR 866.5150
Device class
Class II
Review panel
Immunology
Applicant
Kallestad Laboratories, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code CZQ

Trailing 12 months

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

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