PROFILE-II MODEL 600582— 510(k) K982211
Substantially EquivalentMedtox Diagnostics, Inc.
FDA 510(k) clearance K982211 for PROFILE-II MODEL 600582, Substantially Equivalent on 1998-07-29. Applicant: Medtox Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtox Diagnostics, Inc.
- Product code
- Code DKE
- Device class
- Class 2
- Regulation
- 21 CFR 862.3870
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burlington, NC, US
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