FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)
K Number: K141647
·
Decision Jul 17, 2014
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
144
Applicant Total
27
Review Days
28
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Basic Information
- Device Name
- HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)
- K Number
- K141647
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Healgen Scientific,, LLC
- Date Received
- June 19, 2014
- Decision Date
- July 17, 2014
- Product Code
- DIO
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- 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 |
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