LACTATE DEHYDROGENASE REAGENT SYSTEM— 510(k) K952747
Substantially EquivalentMedical Diagnostic Technologies, Inc.
FDA 510(k) clearance K952747 for LACTATE DEHYDROGENASE REAGENT SYSTEM, Substantially Equivalent on 1995-08-07. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Diagnostic Technologies, Inc.
- Product code
- Code CFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1440
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ventura, CA, US
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