FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIA SYSTEM FOR HUMAN FE-RITIN
K Number: K781527
·
Decision Oct 3, 1978
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
23
Applicant Total
41
Review Days
28
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Basic Information
- Device Name
- RIA SYSTEM FOR HUMAN FE-RITIN
- K Number
- K781527
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Calbiochem-Behring Corp.
- Date Received
- September 5, 1978
- Decision Date
- October 3, 1978
- Product Code
- JMG
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| JMG | Radioimmunoassay (Two-Site Solid Phase), Ferritin | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JMG), ordered by most recent decision date.
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FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
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TINA-QUANT FERRITIN ASSAY
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ELECSYS FERRITIN
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FERR FLEX REAGENT CARTRIDGE
FDA 510(k)
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ACE(TM) CEDIA(R) FERRITIN ASSAY
FDA 510(k)
FDA Class 2
·Immunology
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 |
| K810718 | C-PEPTICE REAGENTS | Mar 31, 1981 | Substantially Equivalent |
| K810669 | PANTRAK E.K. | Mar 31, 1981 | Substantially Equivalent |
| K810309 | RUBELLA ANTIBODIES TEST REAGENTS | Mar 11, 1981 | Substantially Equivalent |