510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042485Substantially Equivalent

Tina-Quant Crp (Latex) Hs Test System (C-Reactive Protein (Latex) High Sensitive)

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042485 is the FDA 510(k) clearance record for TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE), a class II device, cleared for Roche Diagnostics Corp. on under FDA product code NQD (Cardiac C-Reactive Protein, Antigen, Antiserum, And Control). FDA's definition for product code NQD reads: "In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments". FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show one recall naming K042485.

Clearance record

Decision date
Received
(46 days to decision)
Product code
NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Regulation
21 CFR 866.5270
Device class
Class II
Review panel
Immunology
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NQD

Trailing 12 months
1 clearance under product code NQD in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NQD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260