FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COULTER PHOSPHORUS REAGENT
K Number: K900215
·
Decision Feb 8, 1990
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
104
Applicant Total
51
Review Days
22
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Basic Information
- Device Name
- COULTER PHOSPHORUS REAGENT
- K Number
- K900215
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1580
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Coulter Corp.
- Date Received
- January 17, 1990
- Decision Date
- February 8, 1990
- Product Code
- CEO
- 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 |
|---|---|---|---|
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | FDA class 1 | Clinical Chemistry |
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Other Clearances by Coulter Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K993356 | COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES | Apr 20, 2000 | Substantially Equivalent |
| K991070 | COULTER Z2 ANALYZER | May 11, 1999 | Substantially Equivalent |
| K990327 | RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS | Apr 26, 1999 | Substantially Equivalent |
| K990172 | TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA | Apr 13, 1999 | Substantially Equivalent |
| K990352 | COULTER AC T DIFF 2 ANALYZER | Apr 1, 1999 | Substantially Equivalent |
| K984216 | IMMUNO-TROL CONTROL CELLS | Mar 16, 1999 | Substantially Equivalent |
| K982167 | CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 | Nov 9, 1998 | Substantially Equivalent |
| K982166 | CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 | Nov 5, 1998 | Substantially Equivalent |
| K982172 | CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL | Sep 24, 1998 | Substantially Equivalent |
| K973634 | COULTER AC.T DIFF ANALYZER | Oct 29, 1997 | Substantially Equivalent |