FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEMAFLOUR ZP
K Number: K760506
·
Decision Oct 28, 1976
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
2
Review Days
66
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Basic Information
- Device Name
- HEMAFLOUR ZP
- K Number
- K760506
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2560
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Buchler Instruments, Inc.
- Date Received
- August 23, 1976
- Decision Date
- October 28, 1976
- Product Code
- KHO
- 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 |
|---|---|---|---|
| KHO | Fluorometer, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Buchler Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K791312 | CATALOG #4-2520 CHLORIDOMETER CHLORIDE | Aug 16, 1979 | Substantially Equivalent |