FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IRMA TEST, NORDICLAB FERRITIN
K Number: K782157
·
Decision Jan 17, 1979
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
23
Applicant Total
8
Review Days
26
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Basic Information
- Device Name
- IRMA TEST, NORDICLAB FERRITIN
- K Number
- K782157
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Nordiclab Intl.
- Date Received
- December 22, 1978
- Decision Date
- January 17, 1979
- Product Code
- JMG
- Advisory Committee
- Immunology
- Review Advisory Committee
- MI
- 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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ACE(TM) CEDIA(R) FERRITIN ASSAY
FDA 510(k)
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·Immunology
Other Clearances by Nordiclab Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K801988 | NORDICLAB PROSTATIC ACID PHOSPHATASE RIA | Sep 26, 1980 | Substantially Equivalent |
| K801989 | NORDICLAB FERRITIN IRMA TEST | Sep 16, 1980 | Substantially Equivalent |
| K800922 | NORDICLAB PROGESTERONE RIA TEST | May 14, 1980 | Substantially Equivalent |
| K800921 | NORDICLAB TESTOSTERONE RIA TEST | May 14, 1980 | Substantially Equivalent |
| K800920 | NORDICLAB ESTRADIOL RIA TEST | May 14, 1980 | Substantially Equivalent |
| K792189 | NORDICLAB TOTAL ESTRIOL RIA TEST | Nov 13, 1979 | Substantially Equivalent |
| K782099 | RIA TEST, NORDICALB HPL | Jan 10, 1979 | Substantially Equivalent |