510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K954656Substantially Equivalent

Roche Control Serum P

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

K954656 is the FDA 510(k) clearance record for ROCHE CONTROL SERUM P, a class I device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code JJY (Multi-Analyte Controls, All Kinds (Assayed)). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K954656.

Clearance record

Decision date
Received
(72 days to decision)
Product code
JJY Multi-Analyte Controls, All Kinds (Assayed)
Regulation
21 CFR 862.1660
Device class
Class I
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 JJY

Trailing 12 months

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

FDA records show no clearances under product code JJY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JJY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260