510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093954Substantially Equivalent

Bioplex 2200 Anti-Ccp Kit on the Bioplex 2200 Multi-Analyte Detection System

Bio-Rad Laboratories Inc., Benicia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093954 is the FDA 510(k) clearance record for BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, a class II device, cleared for Bio-Rad Laboratories on under FDA product code NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)). FDA's definition for product code NHX reads: "The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis". FDA records list 128 510(k) clearances for Bio-Rad Laboratories, from to . As of , FDA records show 2 recalls naming K093954.

Clearance record

Decision date
Received
(244 days to decision)
Product code
NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Regulation
21 CFR 866.5775
Device class
Class II
Review panel
Immunology
Applicant
Bio-Rad Laboratories Bioplex 2200 Division, Benicia CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NHX

Trailing 12 months

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

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