QCA CHEMISTRY ANALYZER
FDA 510(k) clearance K833998 · decided 1984-01-30
Clearance details
- K-number
- K833998
- Device name
- QCA CHEMISTRY ANALYZER
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1983-11-21
- Decision date
- 1984-01-30
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- JJF
- Device class
- 1
- Regulation number
- 862.2170
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Washington, DC, 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 |
|---|---|---|
| ETI-MAX 3000 (K052794) | DiaSorin, Inc. | 2006-03-31 |
| POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER (K040332) | Arkray, Inc. | 2004-06-16 |
| LIGHTCYCLER INSTRUMENT VERSION 1.2 (K033734) | Roche Diagnostics Corp. | 2003-12-17 |
| PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER (K013654) | Precision Systems, Inc. | 2002-06-05 |
| ROCHE COBAS TAQMAN ANALYZER (K012966) | Roche Molecular Systems, Inc. | 2002-02-01 |
| CARESIDE ANALYZER (K993634) | Careside, Inc. | 1999-12-02 |
| VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA (K973628) | Vital Scientific N.V. | 1998-03-13 |
| CARESIDE ANALYZER (K980056) | Exigent Diagnostics, Inc. | 1998-03-06 |
| MAGO AUTOMATED EIA PROCESSOR (K973177) | Diamedix Corp. | 1997-10-09 |
| SYNERMED IR 200 CHEMISTRY ANALYZER (K971491) | Synermed, Inc. | 1997-06-26 |
| ROCHE COBAS AMPLICOR ANALYZER (K964506) | Roche Molecular Systems, Inc. | 1997-05-21 |
| WINMAX SOFTWARE SYSTEMS (K965103) | Diagnostic Products Corp. | 1997-05-09 |
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 |