510(k) K043267
- Device
- POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
- Applicant
- RANDOX LABORATORIES, LTD.
- 510(k) number
- K043267
- Product code
- CEJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-02-10
- Date received
- 2004-11-26
- Regulation
- 862.1600
- Classification name
- Tetraphenyl Borate, Colorimetry, Potassium
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- P. ARMSTRONG
- Address
- 55 Diamond Rd. Crumlin GB BT29 4QY BT29 4QY
FDA Registration Numbers#
- 3013660430
- 2939693
- 3004493545
- 1832216
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CEJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K943026 | POTASSIUM QVET | Prisma Systems | 1994-12-09 |
| K904033 | REFLOTRON POTASSIUM TEST TABS | Boehringer Mannheim Corp. | 1990-11-06 |
| K902574 | POTASSIUM REAGENT SET | Tech-Co, Inc. | 1990-07-10 |
| K883585 | TECHNICON ASSIST POTASSIUM | Technicon Instruments Corp. | 1988-11-29 |
| K883586 | TECHNICON RA-100 SYSTEM POTASSIUM | Technicon Instruments Corp. | 1988-11-29 |
| K881440 | IQ POTASSIUM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-05-27 |
| K880339 | EASY-TEST POTASSIUM K ITEM NUMBER 19XXX | Em Diagnostic Systems, Inc. | 1988-02-25 |
| K863486 | POTASSIUM TEST | Sclavo, Inc. | 1986-09-29 |
| K861713 | SERUM POTASSIUM REAGENT SET | Sterling Diagnostics, Inc. | 1986-05-23 |
| K853404 | QCA POTASSIUM TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-08-23 |
| K850258 | BCS POTASSIUM TURBIDIMETRIC TEST | Bioclinical Systems, Inc. | 1985-02-07 |
| K832553 | POTASSIUM TEST KIT | Mallinckrodt Critical Care | 1983-09-20 |
| K813608 | POTASSIUM REAGENT SET | Diagnostic Specialties | 1982-01-22 |
| K812677 | UNITEST-POTASSIUM | Biodynamics Corp. | 1981-10-02 |
| K811661 | POTASSIUM TEST | King Diagnostics, Inc. | 1981-06-25 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Decision Summary