FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOCHEK SAMPLE COLLECTION KIT
K Number: K984529
·
Decision Jan 28, 1999
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
2
Review Days
38
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Basic Information
- Device Name
- HEMOCHEK SAMPLE COLLECTION KIT
- K Number
- K984529
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osborn Laboratories, Inc.
- Date Received
- December 21, 1998
- Decision Date
- January 28, 1999
- Product Code
- LCP
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | FDA class 2 | Hematology |
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Other Clearances by Osborn Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K984361 | ORAL-EZE ORAL FLUID COLLECTION SYSTEM | Jan 13, 1999 | Substantially Equivalent |