PMA P790019S007
- Device
- Havab-m Eia Diagnostic Kit
- Applicant
- Abbott Laboratories
- PMA number
- P790019
- Supplement
- S007
- Decision date
- 1996-05-29
Current openFDA PMA Record
- Device
- HAVAB-M EIA DIAGNOSTIC KIT
- Applicant
- Abbott Laboratories
- PMA number
- P790019
- Supplement
- S007
- Product code
- LOL
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Decision date
- 1996-05-29
- Decision code
- APPR
- Date received
- 1994-11-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO EXTEND EXPIRATION DATING TO 8 MONTHS FROM THE DATE OF MANUFACTURE WHEN STORED AT 2-8 DEGREES CELSIUS