510(k) K123986

ACTIM PROM by Alere Scarborough, Inc. — Product Code OAM

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 9, 2014
Date Received: December 26, 2012
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Immunoassay, Insulin-Like Growth Factor Binding Protein-1
Device Class: Class I
Regulation Number: 862.1550
Review Panel: CH
Submission Type

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.

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510(k) K123986

Clearance Details

Device Classification

Other clearances by Alere Scarborough, Inc.

Other clearances for product code OAM