AFP MID-PREGNANCY REFERENCE PREPARATION

FDA Premarket Approval P820077

Pre-market Approval Supplement Details

• Device: AFP MID-PREGNANCY REFERENCE PREPARATION
• Generic Name: Calibrator For Alpha-fetoprotein In Mid-pregnancy Maternal Serum
• Applicant: CENTERS FOR DISEASE CONTROL AND PREVENTION
• Date Received: 1982-10-19
• Decision Date: 1984-11-30
• Notice Date: 1985-01-03
• PMA: P820077
• Supplement: S
• Product Code: LTQ
• Docket Number: 84M-0410
• Advisory Committee: Immunology
• Expedited Review: No
• Combination Product: No
• Applicant Address: CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 Clifton Rd, Ms-c18 atlanta, GA 30333

Supplemental Filings

A PHP Error was encountered

Severity: Notice

Message: Undefined offset: 0

Filename: fda.report/pma_item.php

Line Number: 133

Backtrace:

File: /var/www/fda.report/pma_item.php
Line: 133
Function: _error_handler

Supplement Number	Date	Supplement Type
P820077		Original Filing