510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160570Substantially Equivalent

Creatine Kinase

Roche Diagnostics Operations (Rdo), Indianapolis MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160570 is the FDA 510(k) clearance record for Creatine Kinase, a class II device, cleared for Roche Diagnostics Operations (Rdo) on under FDA product code JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes). FDA records list 14 510(k) clearances for Roche Diagnostics Operations (Rdo), from to . As of , FDA records show one recall naming K160570.

Clearance record

Decision date
Received
(86 days to decision)
Product code
JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostics Operations (Rdo) 9115 Hague Rd., Indianapolis MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JHS

Trailing 12 months

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

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