NICCHECK I— 510(k) K963733
Substantially EquivalentDynagen, Inc.
FDA 510(k) clearance K963733 for NICCHECK I, Substantially Equivalent on 1996-12-13. Applicant: Dynagen, Inc.. Device class: 1.
Clearance details
- Applicant
- Dynagen, Inc.
- Product code
- Code MRS
- Device class
- Class 1
- Regulation
- 21 CFR 862.3220
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
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