NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT— 510(k) K950481
Substantially EquivalentIsolab, Inc.
FDA 510(k) clearance K950481 for NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT, Substantially Equivalent on 1996-02-01. Applicant: Isolab, Inc.. Device class: 1.
Clearance details
- Applicant
- Isolab, Inc.
- Product code
- Code JIA
- Device class
- Class 1
- Regulation
- 21 CFR 862.1310
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Akron, OH, US
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More clearances from Isolab, Inc.
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