FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELEGANCE FERRITIN ELISA
K Number: K904822
·
Decision Nov 29, 1990
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
86
Applicant Total
10
Review Days
36
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Basic Information
- Device Name
- ELEGANCE FERRITIN ELISA
- K Number
- K904822
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Bioclone Australia Pty , Ltd.
- Date Received
- October 24, 1990
- Decision Date
- November 29, 1990
- 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 |
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Other Clearances by Bioclone Australia Pty , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K935049 | ELEGANCE NEONATAL TSH ELISA | Oct 3, 1994 | Substantially Equivalent |
| K922284 | ELEGANCE FT4 ELISA | Jul 10, 1992 | Substantially Equivalent |
| K910419 | BIOCLONE'S ELEGANCE IGE ELISA KIT | Jun 21, 1991 | Substantially Equivalent |
| K910420 | BIOCLONE'S ELEGANCE HCG ELISA KIT | Feb 26, 1991 | Substantially Equivalent |
| K905099 | ELEGANCE TSH ELISA | Dec 18, 1990 | Substantially Equivalent |
| K905098 | ELEGANCE GH ELISA | Dec 6, 1990 | Substantially Equivalent |
| K904387 | BIOCLONES ELEGANCE LH ELISA KIT | Nov 6, 1990 | Substantially Equivalent |
| K904483 | ELEGANCE PROLACTIN ELISA | Nov 5, 1990 | Substantially Equivalent |
| K904405 | BIOCLONES ELEGANCE FSH ELISA KIT | Oct 26, 1990 | Substantially Equivalent |