QUANTITOPE 125I AFP KIT AND CONTROL SERUM

FDA Premarket Approval P800025 S003

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceQUANTITOPE 125I AFP KIT AND CONTROL SERUM
Generic NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
ApplicantBio-Rad Laboratories, Inc.
Date Received1985-04-01
Decision Date1985-07-17
PMAP800025
SupplementS003
Product CodeLOK 
Advisory CommitteeImmunology
Expedited ReviewNo
Combination Product No
Applicant Address Bio-Rad Laboratories, Inc. 3 Boulevard Raymond Poincare' marnes-la-coquette 92430

Supplemental Filings

Supplement NumberDateSupplement Type
P800025Original Filing
S005 1995-12-21 Normal 180 Day Track
S004 1986-03-18
S003 1985-04-01
S002
S001 1984-01-26

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