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

Enzyme Immunoassay, Inhibin-A

21 CFR 862.1260 / Clinical Chemistry
FDA source (opens on fda.gov)

NDR is the FDA product code for Enzyme Immunoassay, Inhibin-A, a class I device type, regulated under 21 CFR 862.1260. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 3 recalls.

Classification record

Product code
NDR
Device name
Enzyme Immunoassay, Inhibin-A
Regulation
21 CFR 862.1260
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
3

Clearances, product code NDR

By decision year
1 clearance under product code NDR with a decision year between 2000 and 2000, 2000 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NDR by decision year
YearClearances
20001

Applicants with the most clearances

Product code NDR
Applicants holding the most 510(k) clearances under product code NDR
ApplicantClearances
Diagnostic Systems Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code