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

Radioimmunoassay, Androstenedione

21 CFR 862.1075 / Clinical Chemistry
FDA source (opens on fda.gov)

CIZ is the FDA product code for Radioimmunoassay, Androstenedione, a class I device type, regulated under 21 CFR 862.1075. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
CIZ
Device name
Radioimmunoassay, Androstenedione
Regulation
21 CFR 862.1075
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
10
Ingested recalls
5

Clearances, product code CIZ

By decision year
10 clearances under product code CIZ with a decision year between 1980 and 1996, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code CIZ by decision year
YearClearances
19801
19831
19842
19851
19862
19941
19951
19961

Applicants with the most clearances

Product code CIZ
Applicants holding the most 510(k) clearances under product code CIZ
ApplicantClearances
Diagnostic Systems Laboratories, Inc.4
Siemens Healthcare Diagnostics Inc.2
Diagnostics Biochem Canada, Inc.1
Immuchem Corp.1
Radioassay Systems Laboratories, Inc.1
Wien Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order