FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUICK CULT SLIDE TEST FECAL OCCULT BLOOD
K Number: K761232
·
Decision Dec 21, 1976
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
96
Applicant Total
2
Review Days
11
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Basic Information
- Device Name
- QUICK CULT SLIDE TEST FECAL OCCULT BLOOD
- K Number
- K761232
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Laboratory Diagnostics Co., Inc.
- Date Received
- December 10, 1976
- Decision Date
- December 21, 1976
- Product Code
- KHE
- 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 |
|---|---|---|---|
| KHE | Reagent, Occult Blood | FDA class 2 | Hematology |
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Other Clearances by Laboratory Diagnostics Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K801668 | QUICK CEPT | Aug 13, 1980 | Substantially Equivalent |