COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT)
FDA 510(k) clearance K020763 · decided 2002-05-10
Clearance details
- K-number
- K020763
- Device name
- COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT)
- Applicant
- Lin-Zhi International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-07
- Decision date
- 2002-05-10
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- DIO
- Device class
- 2
- Regulation number
- 862.3250
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.