ACE PHENOBARBITAL REAGENT/AED CALIBRATORS— 510(k) K973536
Substantially EquivalentSchiapparelli Biosystems, Inc.
FDA 510(k) clearance K973536 for ACE PHENOBARBITAL REAGENT/AED CALIBRATORS, Substantially Equivalent on 1997-11-06. Applicant: Schiapparelli Biosystems, Inc.. Device class: 2.
Clearance details
- Applicant
- Schiapparelli Biosystems, Inc.
- Product code
- Code DLJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3200
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fairfield, NJ, US
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More clearances from Schiapparelli Biosystems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.