FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GLUCOSE 3, INLAB REAGENT STRIPS-URINALY
K Number: K831499
·
Decision Jun 17, 1983
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
23
Applicant Total
3
Review Days
37
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Basic Information
- Device Name
- GLUCOSE 3, INLAB REAGENT STRIPS-URINALY
- K Number
- K831499
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1435
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Laprol Scientific, Inc.
- Date Received
- May 11, 1983
- Decision Date
- June 17, 1983
- Product Code
- JIN
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | FDA class 1 | Clinical Chemistry |
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