MECTEST
FDA 510(k) clearance K973986 · decided 1998-04-24
Clearance details
- K-number
- K973986
- Device name
- MECTEST
- Applicant
- Meco Industries
- Decision
- Substantially Equivalent
- Date received
- 1997-10-20
- Decision date
- 1998-04-24
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- DIO
- Device class
- 2
- Regulation number
- 862.3250
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Walnut, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.