FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CALIBRATOR, BOVINE SERUM
K Number: K781702
·
Decision Nov 15, 1978
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
4
Review Days
36
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Basic Information
- Device Name
- CALIBRATOR, BOVINE SERUM
- K Number
- K781702
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bio-Reagents & Diagnostics, Inc.
- Date Received
- October 10, 1978
- Decision Date
- November 15, 1978
- Product Code
- JIX
- 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
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