APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1— 510(k) K853048
Substantially EquivalentPhotec Diagnostics, Inc.
FDA 510(k) clearance K853048 for APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1, Substantially Equivalent on 1985-08-28. Applicant: Photec Diagnostics, Inc..
Clearance details
- Applicant
- Photec Diagnostics, Inc.
- Product code
- Code DER
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Little Falls, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.