HAVAB-M EIA DIAGNOSTIC KIT
FDA premarket approval P790019/S007 · decided 1996-05-29
Approval details
- PMA number
- P790019
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HAVAB-M EIA DIAGNOSTIC KIT
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Abbott Laboratories
- Date received
- 1994-11-25
- Decision date
- 1996-05-29
- Days to decision
- 551 days
- Decision code
- APPR
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park North, IL
- Statement
- APPROVAL TO EXTEND EXPIRATION DATING TO 8 MONTHS FROM THE DATE OF MANUFACTURE WHEN STORED AT 2-8 DEGREES CELSIUS
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