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

Immunoassay, Insulin-Like Growth Factor Binding Protein-1

21 CFR 862.1550 / Clinical Chemistry
FDA source (opens on fda.gov)

OAM is the FDA product code for Immunoassay, Insulin-Like Growth Factor Binding Protein-1, a class I device type, regulated under 21 CFR 862.1550. FDA's definition for this code reads: "The device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions. The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OAM
Device name
Immunoassay, Insulin-Like Growth Factor Binding Protein-1
FDA definition
The device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions. The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women.
Regulation
21 CFR 862.1550
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
2
Ingested recalls
1

Clearances, product code OAM

By decision year
2 clearances under product code OAM with a decision year between 2007 and 2014, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OAM by decision year
YearClearances
20071
20141

Applicants with the most clearances

Product code OAM
Applicants holding the most 510(k) clearances under product code OAM
ApplicantClearances
Alere Scarborough, Inc.1
Medix Biochemica1

Companies listing this code with FDA

Companies whose registered establishments list this code