ACCESS DIGIWIPE SYSTEM— 510(k) K853141
Substantially EquivalentMedtech Products, Inc.
FDA 510(k) clearance K853141 for ACCESS DIGIWIPE SYSTEM, Substantially Equivalent on 1985-11-18. Applicant: Medtech Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtech Products, Inc.
- Product code
- Code KHE
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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