BILIRUBIN PLUS/PEDIATRIC CONTROLS— 510(k) K943290
Substantially EquivalentMedi-Tech, Inc.
FDA 510(k) clearance K943290 for BILIRUBIN PLUS/PEDIATRIC CONTROLS, Substantially Equivalent on 1994-09-14. Applicant: Medi-Tech, Inc.. Device class: 1.
Clearance details
- Applicant
- Medi-Tech, Inc.
- 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
- Ventura, CA, US
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