FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOSCAN REAGENT STRIPS
K Number: K943008
·
Decision Aug 8, 1994
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
4
Applicant Total
3
Review Days
45
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Basic Information
- Device Name
- BIOSCAN REAGENT STRIPS
- K Number
- K943008
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1115
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genesis Labs, Inc.
- Date Received
- June 24, 1994
- Decision Date
- August 8, 1994
- Product Code
- JJB
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JJB | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | FDA class 1 | Clinical Chemistry |
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