510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K992492Substantially Equivalent

Ptn Test Cartridges for Coaguchek Pro System, Ptn Controls for Coaguchek Pro System

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

K992492 is the FDA 510(k) clearance record for PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code GJS (Test, Time, Prothrombin). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K992492.

Clearance record

Decision date
Received
(99 days to decision)
Product code
GJS Test, Time, Prothrombin
Regulation
21 CFR 864.7750
Device class
Class II
Review panel
Hematology
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., P.O. Box 50457, Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code GJS

Trailing 12 months

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

FDA records show no clearances under product code GJS in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GJS, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260