FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER
K Number: K884378
·
Decision Feb 27, 1989
Classifications
1
FEI Numbers
174
Registration Numbers
174
Same Product Code
207
Applicant Total
51
Review Days
132
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
- DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER
- K Number
- K884378
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Coulter Corp.
- Date Received
- October 18, 1988
- Decision Date
- February 27, 1989
- Product Code
- JJE
- 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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJE), ordered by most recent decision date.
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSION EXL WITH LM SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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 |