510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043341Substantially Equivalent

Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200 Multi-Analyte Detection System

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

K043341 is the FDA 510(k) clearance record for BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, a class II device, cleared for Bio-Rad Laboratories, Inc. on under FDA product code NVI (Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease). FDA's definition for product code NVI reads: "The device is intended to suggest a systemic autoimmune disease association as an aid for differential diagnosis to be evaluated in conjunction with clinical findings and other laboratory tests". FDA records list 128 510(k) clearances for Bio-Rad Laboratories, Inc., from to . As of , FDA records show 2 recalls naming K043341.

Clearance record

Decision date
Received
(328 days to decision)
Product code
NVI Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease
Regulation
21 CFR 862.3100
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Bio-Rad Laboratories, Inc. 6565 185th Ave., NE, Redmond WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NVI

Trailing 12 months

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

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