FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY
K Number: K933464
·
Decision Oct 22, 1993
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
49
Applicant Total
72
Review Days
98
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY
- K Number
- K933464
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1260
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Diagnostics, Inc.
- Date Received
- July 16, 1993
- Decision Date
- October 22, 1993
- Product Code
- CHP
- 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 |
|---|---|---|---|
| CHP | Radioimmunoassay, Estradiol | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CHP), ordered by most recent decision date.
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
17 B-ESTRADIOL (ELISA)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACS ESTADIOL-6 II
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
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 |
| K950570 | STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY | Apr 11, 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 |