510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K912615Substantially Equivalent

Roche Cobas Argos 5 Diff

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

K912615 is the FDA 510(k) clearance record for ROCHE COBAS ARGOS 5 DIFF, a class II device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code GZI (Stimulator, Neuromuscular, External Functional). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K912615.

Clearance record

Decision date
Received
(106 days to decision)
Product code
GZI Stimulator, Neuromuscular, External Functional
Regulation
21 CFR 882.5810
Device class
Class II
Review panel
Neurology
Applicant
Roche Diagnostic Systems, Inc. One Sunset Ave., Montclair NJ
510(k) summary
Statement
Third party review
No

Clearances, product code GZI

Trailing 12 months

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

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