FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REDI-TEST COCAINE
K Number: K991110
·
Decision Jul 26, 1999
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
144
Applicant Total
6
Review Days
116
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Basic Information
- Device Name
- REDI-TEST COCAINE
- K Number
- K991110
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Redwood Biotech, Inc.
- Date Received
- April 1, 1999
- Decision Date
- July 26, 1999
- Product Code
- DIO
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DIO), ordered by most recent decision date.
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Emit II Plus Cocaine Metabolite Assay
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Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
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Other Clearances by Redwood Biotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K000979 | REDI-SCREEN | Apr 10, 2000 | Substantially Equivalent |
| K993100 | REDI-SCREEN | Oct 6, 1999 | Substantially Equivalent |
| K991698 | REDI-TEST PCP | Aug 25, 1999 | Substantially Equivalent |
| K991504 | REDI-TEST METHAMPHETAMINE | Jul 22, 1999 | Substantially Equivalent |
| K990870 | REDI-TEST THC | Apr 27, 1999 | Substantially Equivalent |