510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171655Substantially Equivalent

cobas m 511 integrated hematology analyzer

Roche Diagnostics Hematology, Inc., Westborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171655 is the FDA 510(k) clearance record for cobas m 511 integrated hematology analyzer, a class II device, cleared for Roche Diagnostics Hematology, Inc. on under FDA product code GKZ (Counter, Differential Cell). FDA records list one 510(k) clearance for Roche Diagnostics Hematology, Inc. As of , FDA records show one recall naming K171655.

Clearance record

Decision date
Received
(270 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Roche Diagnostics Hematology, Inc. 69 Milk St., Suite 120, Westborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GKZ

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