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.. Device class: 2.
Clearance details
- Applicant
- Photec Diagnostics, Inc.
- Product code
- Code DER
- Device class
- Class 2
- Regulation
- 21 CFR 866.5580
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Little Falls, NJ, US
Recent devices under product code DER
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