FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TESTOTERONE ELISA
K Number: K973900
·
Decision Feb 24, 1998
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
88
Applicant Total
6
Review Days
133
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Basic Information
- Device Name
- TESTOTERONE ELISA
- K Number
- K973900
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1680
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kmi Diagnostics, Inc.
- Date Received
- October 14, 1997
- Decision Date
- February 24, 1998
- Product Code
- CDZ
- 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 |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FDA class 1 | Clinical Chemistry |
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Other Clearances by Kmi Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K010790 | CORTISOL LIA | Jan 29, 2002 | Substantially Equivalent |
| K990073 | CALCITONIN | May 11, 1999 | Substantially Equivalent |
| K973901 | 17 B-ESTRADIOL (ELISA) | Nov 24, 1997 | Substantially Equivalent |
| K973898 | PROGESTERONE ELISA | Nov 13, 1997 | Substantially Equivalent |
| K973897 | DHEA-S | Nov 13, 1997 | Substantially Equivalent |