FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E
K Number: K944513
·
Decision Dec 2, 1994
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
672
Applicant Total
7
Review Days
78
Basic Information
- Device Name
- LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E
- K Number
- K944513
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- INTERNATIONAL ENZYMES, INC.
- Date Received
- September 15, 1994
- Decision Date
- December 2, 1994
- Product Code
- JJY
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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| K Number | Device Name | ||
|---|---|---|---|
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| K953927 | LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM | Sep 15, 1995 | Substantially Equivalent |
| K953926 | LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM | Sep 15, 1995 | Substantially Equivalent |
| K950802 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM | Jun 1, 1995 | Substantially Equivalent |
| K944486 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E | Dec 2, 1994 | Substantially Equivalent |