FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY
K Number: K950570
·
Decision Apr 11, 1995
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
56
Applicant Total
72
Review Days
67
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Basic Information
- Device Name
- STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY
- K Number
- K950570
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1620
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Diagnostics, Inc.
- Date Received
- February 3, 1995
- Decision Date
- April 11, 1995
- 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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ELECSYS PROGESTERONE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VIDAS PROESTERONE (PRG) (30 409)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Baxter Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934458 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | Jul 18, 1995 | Substantially Equivalent |
| K950817 | DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI | Apr 25, 1995 | Substantially Equivalent |
| K935704 | DRIED GRAM-NEGATIVE MIC//COMBO PANELS | Apr 14, 1995 | Substantially Equivalent |
| K945235 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | Mar 7, 1995 | Substantially Equivalent |
| K941030 | DRIED GRAM-NEGATIVE CEFPODOXIME | Feb 16, 1995 | Substantially Equivalent |
| K940917 | LORACARBEF GRAM-NAGATIVE PANELS | Feb 8, 1995 | Substantially Equivalent |
| K941459 | GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX | Feb 3, 1995 | Substantially Equivalent |
| K941317 | DRIED GRAM NEGATIVE/CEFMETAZOLE | Jan 31, 1995 | Substantially Equivalent |
| K942089 | MICRODILUTION/LORACARBEF PANELS | Jan 9, 1995 | Substantially Equivalent |
| K942267 | DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE | Jan 9, 1995 | Substantially Equivalent |