ACE HDL-C REAGENT— 510(k) K971526
Substantially EquivalentSchiapparelli Biosystems, Inc.
FDA 510(k) clearance K971526 for ACE HDL-C REAGENT, Substantially Equivalent on 1997-05-21. Applicant: Schiapparelli Biosystems, Inc.. Device class: 1.
Clearance details
- Applicant
- Schiapparelli Biosystems, Inc.
- Product code
- Code LBS
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fairfield, NJ, US
Recent devices under product code LBS
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