PMA P830017
- Device
- 9EPANOSTIKA(TM) ANTI-HAV IGM
- Applicant
- Organon Teknika Corp.
- PMA number
- P830017
- Supplement
- S001
- Product code
- LOL
- Decision date
- 1990-03-21
- Generic name
- Hepatitis a test (antibody and igm antibody)
Current openFDA PMA Record#
- Device
- 9EPANOSTIKA(TM) ANTI-HAV IGM
- Applicant
- Organon Teknika Corp.
- PMA number
- P830017
- Supplement
- S001
- Product code
- LOL
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Decision date
- 1990-03-21
- Decision code
- APPR
- Date received
- 1989-08-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier