HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)— 510(k) K904293
Substantially EquivalentHichem Diagnostics
FDA 510(k) clearance K904293 for HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237), Substantially Equivalent on 1990-10-12. Applicant: Hichem Diagnostics. Device class: 1.
Clearance details
- Applicant
- Hichem Diagnostics
- 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
- Brea, CA, US
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