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

Differential Rate Kinetic Method, Cpk Or Isoenzymes

21 CFR 862.1215 / Clinical Chemistry
FDA source (opens on fda.gov)

JHS is the FDA product code for Differential Rate Kinetic Method, Cpk Or Isoenzymes, a class II device type, regulated under 21 CFR 862.1215. As of , FDA records hold 38 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
JHS
Device name
Differential Rate Kinetic Method, Cpk Or Isoenzymes
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
38
Ingested recalls
11

Clearances, product code JHS

By decision year
38 clearances under product code JHS with a decision year between 1978 and 2016, 1979 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code JHS by decision year
YearClearances
19783
19797
19803
19813
19822
19841
19851
19862
19871
19881
19902
19943
19951
19961
19981
19992
20061
20081
20111
20161

Applicants with the most clearances

Product code JHS
Applicants holding the most 510(k) clearances under product code JHS
ApplicantClearances
Smithkline Diagnostics, Inc.4
Careside, Inc.2
Siemens Healthcare Diagnostics Inc.2
Dupont Medical Products2
Eastman Kodak Company2
Fisher Scientific Company L.L.C.2
Intl. Immunoassay Laboratories, Inc.2
Worthington Diagnostic Systems2
Alfa Wassermann Diagnostic Technologies, Inc.1
Baxter Healthcare Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code