FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROGESTERONE ELISA
K Number: K973898
·
Decision Nov 13, 1997
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
56
Applicant Total
6
Review Days
30
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Basic Information
- Device Name
- PROGESTERONE ELISA
- K Number
- K973898
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1620
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kmi Diagnostics, Inc.
- Date Received
- October 14, 1997
- Decision Date
- November 13, 1997
- Product Code
- JLS
- 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 |
|---|---|---|---|
| JLS | Radioimmunoassay, Progesterone | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JLS), ordered by most recent decision date.
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA
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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 |
| K973900 | TESTOTERONE ELISA | Feb 24, 1998 | Substantially Equivalent |
| K973901 | 17 B-ESTRADIOL (ELISA) | Nov 24, 1997 | Substantially Equivalent |
| K973897 | DHEA-S | Nov 13, 1997 | Substantially Equivalent |