FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS CORE FERRITIN EIA
K Number: K920829
·
Decision Jun 19, 1992
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
23
Applicant Total
296
Review Days
116
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Basic Information
- Device Name
- COBAS CORE FERRITIN EIA
- K Number
- K920829
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Roche Diagnostic Systems, Inc.
- Date Received
- February 24, 1992
- Decision Date
- June 19, 1992
- 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)
FDA Class 2
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ACE(TM) CEDIA(R) FERRITIN ASSAY
FDA 510(k)
FDA Class 2
·Immunology
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|---|---|---|---|
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| K983556 | ABUSCREEN ONLINE BENZ 300 CALIBRATORS | Dec 15, 1998 | Substantially Equivalent |
| K983555 | ABUSCREEN ONLINE BENZ 200 CALIBRATORS | Dec 15, 1998 | Substantially Equivalent |
| K983697 | MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE | Dec 11, 1998 | Substantially Equivalent |
| K983700 | MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE | Dec 11, 1998 | Substantially Equivalent |
| K983701 | MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS | Dec 11, 1998 | Substantially Equivalent |
| K983699 | MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES | Dec 11, 1998 | Substantially Equivalent |
| K983703 | MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE | Dec 11, 1998 | Substantially Equivalent |