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

Colorimetric Method, Cpk Or Isoenzymes

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

JHY is the FDA product code for Colorimetric Method, Cpk Or Isoenzymes, a class II device type, regulated under 21 CFR 862.1215. As of , FDA records hold 40 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
JHY
Device name
Colorimetric 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
40
Ingested recalls
2

Clearances, product code JHY

By decision year
40 clearances under product code JHY with a decision year between 1976 and 2015, 1988 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code JHY by decision year
YearClearances
19762
19792
19801
19821
19833
19841
19851
19861
19873
19885
19893
19901
19911
19923
19931
19951
19961
19972
20022
20071
20131
20142
20151

Applicants with the most clearances

Product code JHY
Applicants holding the most 510(k) clearances under product code JHY
ApplicantClearances
Hybritech, Inc.5
Roche Diagnostics GmbH3
Abbott Medical2
Intl. Immunoassay Laboratories, Inc.2
Roche Diagnostic Systems, Inc.2
American Research Products Co.1
Amersham Corp.1
Amresco, Inc.1
Bayer Corp.1
BD Becton Dickinson Vacutainer Systems Preanalytic1

Companies listing this code with FDA

Companies whose registered establishments list this code