RAMP PROGESTURINE PDG ASSAY--48 TEST KIT— 510(k) K860924

Substantially Equivalent

Monoclonal Antibodies, Inc.

FDA 510(k) clearance K860924 for RAMP PROGESTURINE PDG ASSAY--48 TEST KIT, Substantially Equivalent on 1986-07-02. Applicant: Monoclonal Antibodies, Inc.. Device class: 1.

Clearance details

Applicant
Monoclonal Antibodies, Inc.
Product code
Code JLS
Device class
Class 1
Regulation
21 CFR 862.1620
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mountain View, CA, US
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