RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)
FDA 510(k) clearance K020716 · decided 2002-05-06
Clearance details
- K-number
- K020716
- Device name
- RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)
- Applicant
- Rapid Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-05
- Decision date
- 2002-05-06
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- DJG
- Device class
- 2
- Regulation number
- 862.3650
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Burlingame, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.