FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DACOS PLUS LYTES OPTION
K Number: K843239
·
Decision Oct 17, 1984
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
88
Applicant Total
101
Review Days
56
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 PLUS LYTES OPTION
- K Number
- K843239
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1600
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Coulter Electronics, Inc.
- Date Received
- August 22, 1984
- Decision Date
- October 17, 1984
- Product Code
- CEM
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| CEM | Electrode, Ion Specific, Potassium | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEM), ordered by most recent decision date.
ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ABL90 FLEX PLUS System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EasyStat 300
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ISE Electrodes
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FLEXLAB 3.6, ACCELERATOR A3600
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Coulter Electronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923951 | CD8 CYTOSPHERES KIT | Apr 25, 1994 | Substantially Equivalent |
| K930119 | COULTER RETIC-C CELL CONTROL | Apr 5, 1993 | Substantially Equivalent |
| K921279 | CD4 CYTOSPHERES KIT | Dec 29, 1992 | Substantially Equivalent |
| K923530 | COULTER MULTI-Q-PREP | Oct 14, 1992 | Substantially Equivalent |
| K922181 | COULTER MH009 | Aug 17, 1992 | Substantially Equivalent |
| K922704 | COULTER MAXM W/ AUTOLOADER | Jul 27, 1992 | Substantially Equivalent |
| K921567 | COULTER MH017 | Jul 6, 1992 | Substantially Equivalent |
| K912133 | PX COULTER(R) CELL CONTROL | Jul 17, 1991 | Substantially Equivalent |
| K911385 | COULTER(R) MH010 | Jun 17, 1991 | Substantially Equivalent |
| K905771 | COULTER DART AST (GOT) REAGENT | Feb 26, 1991 | Substantially Equivalent |