LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL— 510(k) K883247
Substantially EquivalentQuantimetrix Medical Industries
FDA 510(k) clearance K883247 for LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL, Substantially Equivalent on 1988-09-13. Applicant: Quantimetrix Medical Industries. Device class: 1.
Clearance details
- Applicant
- Quantimetrix Medical Industries
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hawthorne, CA, US
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