CARDIOISOZYME, CK/LD ISOENZYME CONTROL— 510(k) K970856
Substantially EquivalentMedical Analysis Systems, Inc.
FDA 510(k) clearance K970856 for CARDIOISOZYME, CK/LD ISOENZYME CONTROL, Substantially Equivalent on 1997-04-08. Applicant: Medical Analysis Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Medical Analysis Systems, 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
- Camarillo, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.