510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K922811Substantially Equivalent

Roche Cobas Futura Glucose

Roche Diagnostic Systems, Inc., Branchburg NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922811 is the FDA 510(k) clearance record for ROCHE COBAS FUTURA GLUCOSE, a class II device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code CFR (Hexokinase, Glucose). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K922811.

Clearance record

Decision date
Received
(231 days to decision)
Product code
CFR Hexokinase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostic Systems, Inc. 1080 Us Hwy. 202, Branchburg NJ
510(k) summary
Statement
Third party review
No

Clearances, product code CFR

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