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

Chromatographic Separation, Cpk Isoenzymes

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

JHT is the FDA product code for Chromatographic Separation, Cpk Isoenzymes, a class II device type, regulated under 21 CFR 862.1215. As of , FDA records hold 21 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JHT
Device name
Chromatographic Separation, Cpk 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
21
Ingested recalls
0

Clearances, product code JHT

By decision year
21 clearances under product code JHT with a decision year between 1976 and 2002, 1990 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JHT by decision year
YearClearances
19761
19771
19792
19811
19822
19832
19873
19882
19904
19931
19991
20021

Applicants with the most clearances

Product code JHT
Applicants holding the most 510(k) clearances under product code JHT
ApplicantClearances
Intl. Immunoassay Laboratories, Inc.4
Helena Laboratories, Corp.3
Coulter Electronics, Inc.2
Boehringer Mannheim Corp.1
Clinical Sciences, Inc.1
Data Medical Associates, Inc.1
Diagnostic Chemicals, Ltd. (USA)1
Diagnostic Systems Laboratories, Inc.1
Gelman Sciences, Inc.1
Gemini, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code