FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEMOCHEK URINE COLLECTION KIT
K Number: K991800
·
Decision Sep 24, 1999
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
12
Applicant Total
4
Review Days
121
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Basic Information
- Device Name
- HEMOCHEK URINE COLLECTION KIT
- K Number
- K991800
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1645
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osborn Group, Inc.
- Date Received
- May 26, 1999
- Decision Date
- September 24, 1999
- Product Code
- JIQ
- 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 |
|---|---|---|---|
| JIQ | Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | FDA class 1 | Clinical Chemistry |
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