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
K012361Substantially Equivalent

Tina-Quant Complement C3c Test System

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

K012361 is the FDA 510(k) clearance record for TINA-QUANT COMPLEMENT C3C TEST SYSTEM, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code CZW (Complement C3, Antigen, Antiserum, Control). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K012361.

Clearance record

Decision date
Received
(127 days to decision)
Product code
CZW Complement C3, Antigen, Antiserum, Control
Regulation
21 CFR 866.5240
Device class
Class II
Review panel
Immunology
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code CZW

Trailing 12 months

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

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