BILIRUBIN CALIBRATOR #65071— 510(k) K822479
Substantially EquivalentEmd Chemicals, Inc.
FDA 510(k) clearance K822479 for BILIRUBIN CALIBRATOR #65071, Substantially Equivalent on 1982-09-14. Applicant: Emd Chemicals, Inc.. Device class: 2.
Clearance details
- Applicant
- Emd Chemicals, Inc.
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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