QCA POTASSIUM TEST KIT
FDA 510(k) clearance K853404 · decided 1985-08-23
Clearance details
- K-number
- K853404
- Device name
- QCA POTASSIUM TEST KIT
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1985-08-12
- Decision date
- 1985-08-23
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- CEJ
- Device class
- 2
- Regulation number
- 862.1600
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Paramus, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 (K043267) | Randox Laboratories, Ltd. | 2005-02-10 |
| POTASSIUM QVET (K943026) | Prisma Systems | 1994-12-09 |
| REFLOTRON POTASSIUM TEST TABS (K904033) | Boehringer Mannheim Corp. | 1990-11-06 |
| POTASSIUM REAGENT SET (K902574) | Tech-Co, Inc. | 1990-07-10 |
| TECHNICON RA-100 SYSTEM POTASSIUM (K883586) | Technicon Instruments Corp. | 1988-11-29 |
| TECHNICON ASSIST POTASSIUM (K883585) | Technicon Instruments Corp. | 1988-11-29 |
| IQ POTASSIUM (K881440) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-05-27 |
| EASY-TEST POTASSIUM K ITEM NUMBER 19XXX (K880339) | Em Diagnostic Systems, Inc. | 1988-02-25 |
| POTASSIUM TEST (K863486) | Sclavo, Inc. | 1986-09-29 |
| SERUM POTASSIUM REAGENT SET (K861713) | Sterling Diagnostics, Inc. | 1986-05-23 |
| BCS POTASSIUM TURBIDIMETRIC TEST (K850258) | Bioclinical Systems, Inc. | 1985-02-07 |
| POTASSIUM TEST KIT (K832553) | Mallinckrodt Critical Care | 1983-09-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |