510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K063823Substantially Equivalent

Coaguchek Xs Pt Controls

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

K063823 is the FDA 510(k) clearance record for COAGUCHEK XS PT CONTROLS, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code GGN (Plasma, Coagulation Control). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K063823.

Clearance record

Decision date
Received
(34 days to decision)
Product code
GGN Plasma, Coagulation Control
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GGN

Trailing 12 months

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

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