FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
C-PEPTICE REAGENTS
K Number: K810718
·
Decision Mar 31, 1981
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
9
Applicant Total
41
Review Days
14
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Basic Information
- Device Name
- C-PEPTICE REAGENTS
- K Number
- K810718
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1135
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Calbiochem-Behring Corp.
- Date Received
- March 17, 1981
- Decision Date
- March 31, 1981
- Product Code
- JKD
- 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 |
|---|---|---|---|
| JKD | Radioimmunoassay, C-Peptides Of Proinsulin | FDA class 1 | Clinical Chemistry |
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Other Clearances by Calbiochem-Behring Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K831811 | REVOLUTION RADIAL IMMUNODIFFUSION PLATE | Jul 28, 1983 | Substantially Equivalent |
| K831036 | ENA TEST KIT SM & RNP AUTO ANTIBODY | Apr 27, 1983 | Substantially Equivalent |
| K830214 | AFT SYSTEM III | Mar 9, 1983 | Substantially Equivalent |
| K820812 | CREATINE KINASE-MB KIT | Apr 12, 1982 | Substantially Equivalent |
| K813493 | ENZYGNOST TM RUBELLA IGM | Mar 4, 1982 | Substantially Equivalent |
| K820088 | AFT SYSTEM PROFICIENCY TESTING PROGRAM | Jan 26, 1982 | Substantially Equivalent |
| K812458 | PADAC | Sep 23, 1981 | Substantially Equivalent |
| K810669 | PANTRAK E.K. | Mar 31, 1981 | Substantially Equivalent |
| K810309 | RUBELLA ANTIBODIES TEST REAGENTS | Mar 11, 1981 | Substantially Equivalent |
| K810404 | RHEUMATOID FACTORS REFERENCE SERUM | Mar 11, 1981 | Substantially Equivalent |