APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN— 510(k) K853174
Substantially EquivalentPhotec Diagnostics, Inc.
FDA 510(k) clearance K853174 for APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN, Substantially Equivalent on 1985-08-22. Applicant: Photec Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Photec Diagnostics, Inc.
- Product code
- Code MSJ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Little Falls, NJ, US
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More clearances from Photec Diagnostics, Inc.
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