PROFILE-II MODEL 600582
FDA 510(k) clearance K982211 · decided 1998-07-29
Clearance details
- K-number
- K982211
- Device name
- PROFILE-II MODEL 600582
- Applicant
- Medtox Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-06-23
- Decision date
- 1998-07-29
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- DKE
- Device class
- 2
- Regulation number
- 862.3870
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Burlington, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.