FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE
K Number: K864966
·
Decision Jan 9, 1987
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
3
Applicant Total
6
Review Days
18
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Basic Information
- Device Name
- ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE
- K Number
- K864966
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1280
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Diagnostics Biochem Canada, Inc.
- Date Received
- December 22, 1986
- Decision Date
- January 9, 1987
- Product Code
- CGF
- 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 |
|---|---|---|---|
| CGF | Radioimmunoassay, Estrone | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGF), ordered by most recent decision date.
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IMMOPHASE D-TE 3 RADIOIMMUNOASSAY
FDA 510(k)
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Other Clearances by Diagnostics Biochem Canada, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030730 | FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT | Aug 18, 2003 | Substantially Equivalent |
| K014120 | TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) | Feb 8, 2002 | Substantially Equivalent |
| K832297 | HYDROXYPROGESTERONE-17 | Sep 1, 1983 | Substantially Equivalent |
| K801729 | ANDROSTENEDIONE RADIOIMMUNOASSAY KIT | Oct 31, 1980 | Substantially Equivalent |
| K781310 | HUMAN CHORIONIC GONADO.-BETA RIA KIT | Aug 31, 1978 | Substantially Equivalent |