ACE T4 REAGENT T4 CALIBRATORS— 510(k) K981377
Substantially EquivalentSchiapparelli Biosystems, Inc.
FDA 510(k) clearance K981377 for ACE T4 REAGENT T4 CALIBRATORS, Substantially Equivalent on 1998-06-10. Applicant: Schiapparelli Biosystems, Inc.. Device class: 2.
Clearance details
- Applicant
- Schiapparelli Biosystems, Inc.
- Product code
- Code KLI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1700
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fairfield, NJ, US
Recent devices under product code KLI
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