FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATALOG #4-2520 CHLORIDOMETER CHLORIDE
K Number: K791312
·
Decision Aug 16, 1979
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
244
Applicant Total
2
Review Days
36
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Basic Information
- Device Name
- CATALOG #4-2520 CHLORIDOMETER CHLORIDE
- K Number
- K791312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Buchler Instruments, Inc.
- Date Received
- July 11, 1979
- Decision Date
- August 16, 1979
- Product Code
- JIT
- 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 |
|---|---|---|---|
| JIT | Calibrator, Secondary | FDA class 2 | Clinical Chemistry |
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Other Clearances by Buchler Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K760506 | HEMAFLOUR ZP | Oct 28, 1976 | Substantially Equivalent |