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
K851284Substantially Equivalent

Radial Immuno-Diffusion Plates Iga, Igd, Igg & Igm

Cooper Biomedical, Inc., Malvern PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851284 is the FDA 510(k) clearance record for RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM, a class II device, cleared for Cooper Biomedical, Inc. on under FDA product code CZP (Iga, Antigen, Antiserum, Control). FDA records list 19 510(k) clearances for Cooper Biomedical, Inc., from to . As of , FDA records show no recalls naming K851284.

Clearance record

Decision date
Received
(71 days to decision)
Product code
CZP Iga, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Cooper Biomedical, Inc. One Technology Ct., Malvern PA
Third party review
No

Clearances, product code CZP

Trailing 12 months

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

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