FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOCLONES ELEGANCE LH ELISA KIT
K Number: K904387
·
Decision Nov 6, 1990
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
10
Review Days
42
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Basic Information
- Device Name
- BIOCLONES ELEGANCE LH ELISA KIT
- K Number
- K904387
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bioclone Australia Pty , Ltd.
- Date Received
- September 25, 1990
- Decision Date
- November 6, 1990
- Product Code
- CEP
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | FDA class 1 | Clinical Chemistry |
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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 |
| K904822 | ELEGANCE FERRITIN ELISA | Nov 29, 1990 | Substantially Equivalent |
| K904483 | ELEGANCE PROLACTIN ELISA | Nov 5, 1990 | Substantially Equivalent |
| K904405 | BIOCLONES ELEGANCE FSH ELISA KIT | Oct 26, 1990 | Substantially Equivalent |