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

Radioimmunoassay, Androsterone

21 CFR 862.1080 / Clinical Chemistry
FDA source (opens on fda.gov)

CIY is the FDA product code for Radioimmunoassay, Androsterone, a class I device type, regulated under 21 CFR 862.1080. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
CIY
Device name
Radioimmunoassay, Androsterone
Regulation
21 CFR 862.1080
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
1
Ingested recalls
0

Clearances, product code CIY

By decision year
1 clearance under product code CIY with a decision year between 1977 and 1977, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CIY by decision year
YearClearances
19771

Applicants with the most clearances

Product code CIY
Applicants holding the most 510(k) clearances under product code CIY
ApplicantClearances
Wien Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code CIY.