510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K953448Substantially Equivalent

Roche Cobas Micros Hematology Analyzer

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

K953448 is the FDA 510(k) clearance record for ROCHE COBAS MICROS HEMATOLOGY ANALYZER, a class II device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code GKZ (Counter, Differential Cell). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K953448.

Clearance record

Decision date
Received
(88 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Roche Diagnostic Systems, Inc. 1080 Us Hwy. 202, Branchburg NJ
510(k) summary
Summary
Third party review
No

Clearances, product code GKZ

Trailing 12 months
4 clearances under product code GKZ 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 GKZ, trailing twelve months
MonthClearances
December 20250
January 20261
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260