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

Radioimmunoassay, Aldosterone

21 CFR 862.1045 / Clinical Chemistry
FDA source (opens on fda.gov)

CJM is the FDA product code for Radioimmunoassay, Aldosterone, a class II device type, regulated under 21 CFR 862.1045. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CJM
Device name
Radioimmunoassay, Aldosterone
Regulation
21 CFR 862.1045
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
12
Ingested recalls
0

Clearances, product code CJM

By decision year
12 clearances under product code CJM with a decision year between 1977 and 2015, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CJM by decision year
YearClearances
19771
19781
19801
19831
19841
19861
19921
19951
20031
20051
20131
20151

Applicants with the most clearances

Product code CJM
Applicants holding the most 510(k) clearances under product code CJM
ApplicantClearances
Siemens Healthcare Diagnostics Inc.2
Diagnostic Systems Laboratories, Inc.2
Nichols Institute Diagnostics2
Abbott Medical1
Diasorin Inc.1
Immunodiagnostic Systems Ltd.1
Radioassay Systems Laboratories, Inc.1
Serono Laboratories, Inc.1
Sorin Biomedica, Fiat, USA, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code