FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIA-PACK FER CALIBRATION VERIFICATION TEST SET
K Number: K924858
·
Decision Dec 15, 1992
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
86
Applicant Total
41
Review Days
78
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AIA-PACK FER CALIBRATION VERIFICATION TEST SET
- K Number
- K924858
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tosoh Medics, Inc.
- Date Received
- September 28, 1992
- Decision Date
- December 15, 1992
- Product Code
- DBF
- 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 |
|---|---|---|---|
| DBF | Ferritin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DBF), ordered by most recent decision date.
LIAISON Ferritin
FDA 510(k)
FDA Class 2
·Immunology
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
FDA 510(k)
FDA Class 2
·Immunology
Atellica IM Ferritin Assay
FDA 510(k)
FDA Class 2
·Immunology
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
FDA 510(k)
FDA Class 2
·Immunology
K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Immunology
ADVIA CHEMISTRY FERRITIN (FRT) METHOD
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Tosoh Medics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023893 | ST AIA-PACK CEA ENZYME IMMUNOASSAY | Dec 18, 2002 | Substantially Equivalent |
| K023894 | ST AIA-PACK AFP ENZYME IMMUNOASSAY | Dec 17, 2002 | Substantially Equivalent |
| K023091 | ST AIA-PACK TESTOSTERONE ASSAY | Dec 17, 2002 | Substantially Equivalent |
| K023891 | ST AIA-PACK CA 125 ENZYME IMMUNOASSAY | Dec 6, 2002 | Substantially Equivalent |
| K020489 | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE | May 14, 2002 | Substantially Equivalent |
| K012820 | AIA-PACK CTNI 2ND-GEN ASSAY | Dec 14, 2001 | Substantially Equivalent |
| K011434 | G7 AUTOMATED HPLC ANALYZER | Sep 18, 2001 | Substantially Equivalent |
| K010796 | AIA-PACK BRCA, ST AIA PACK BRCA | Aug 16, 2001 | Substantially Equivalent |
| K992365 | AIA-PACK FOLATE ASSAY | Aug 10, 1999 | Substantially Equivalent |
| K990431 | AIA-PACK CA 125 | Jun 3, 1999 | Substantially Equivalent |