BIO-CHEM ANALYZER, MODEL 100— 510(k) K040750
Substantially EquivalentClinical Analysis Corporation, Inc.
FDA 510(k) clearance K040750 for BIO-CHEM ANALYZER, MODEL 100, Substantially Equivalent on 2004-10-28. Applicant: Clinical Analysis Corporation, Inc.. Device class: 2.
Clearance details
- Applicant
- Clinical Analysis Corporation, Inc.
- Product code
- Code CEM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1600
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Quakertown, PA, US
Recent devices under product code CEM
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