CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL— 510(k) K946145
Substantially EquivalentClinical Controls, Inc.
FDA 510(k) clearance K946145 for CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL, Substantially Equivalent on 1995-01-24. Applicant: Clinical Controls, Inc.. Device class: 1.
Clearance details
- Applicant
- Clinical Controls, Inc.
- Product code
- Code JJT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grover Beach, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.