CHROMOLIZE TPA ASSAY KIT— 510(k) K962489
Substantially EquivalentMedical Diagnostic Technologies, Inc.
FDA 510(k) clearance K962489 for CHROMOLIZE TPA ASSAY KIT, Substantially Equivalent on 1996-07-31. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Diagnostic Technologies, Inc.
- Product code
- Code GGP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7290
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ventura, CA, US
Recent devices under product code GGP
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