510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K011684Substantially Equivalent

Influenza A/b Rapid Test, Cat No 2158 663

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

K011684 is the FDA 510(k) clearance record for INFLUENZA A/B RAPID TEST, CAT NO 2158 663, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code PSZ (Devices Detecting Influenza A, B, And C Virus Antigens). FDA's definition for product code PSZ reads: "An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection". FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K011684.

Clearance record

Decision date
Received
(184 days to decision)
Product code
PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Regulation
21 CFR 866.3328
Device class
Class II
Review panel
Microbiology
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., P.O. Box 50457, Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code PSZ

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