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

Control, Hemoglobin, Abnormal

21 CFR 864.7415 / Hematology
FDA source (opens on fda.gov)

JCM is the FDA product code for Control, Hemoglobin, Abnormal, a class II device type, regulated under 21 CFR 864.7415. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JCM
Device name
Control, Hemoglobin, Abnormal
Regulation
21 CFR 864.7415
Device class
Class II
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
1

Clearances, product code JCM

By decision year
12 clearances under product code JCM with a decision year between 1982 and 2005, 1991 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JCM by decision year
YearClearances
19822
19913
19921
19931
19941
19951
19991
20011
20051

Applicants with the most clearances

Product code JCM
Applicants holding the most 510(k) clearances under product code JCM
ApplicantClearances
Isolab, Inc.4
Helena Laboratories, Corp.2
Bio-Rad1
Cantebury Scientific, Ltd.1
Canterbury Health Laboratories1
Creative Laboratory Products, Inc.1
Diagnostic Technology, Inc.1
Roche Diagnostic Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code