CDM
FDA 510(k) clearance K960392 · decided 1996-07-08
Clearance details
- K-number
- K960392
- Device name
- CDM
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 1996-01-29
- Decision date
- 1996-07-08
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- LDM
- Device class
- 1
- Regulation number
- 862.2260
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hercules, CA, 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 |
|---|---|---|
| ALLIANCE 2690 SEPARATIONS MODULE (K961557) | Waters Corporation | 1996-07-05 |
| BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM (K942451) | Bio-Rad | 1994-11-10 |
| WATERS(TM) LC MODULE I FOR CLINICAL USE (K922388) | Millipore Corp. | 1992-09-11 |
| WATERS 717 AUTOSAMPLER (K920136) | Millipore Corp. | 1992-02-19 |
| MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE (K903647) | Millipore Corp. | 1990-09-11 |
| MODEL 250 LIQUID CHROMOTAGRAPHY PUMP (K884886) | The Perkin-Elmer Corp. | 1989-02-02 |
| HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM (K872582) | Millipore Corp. | 1987-07-16 |
| WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM (K870949) | Millipore Corp. | 1987-04-22 |
| ISOPURE LC SYSTEM (K862178) | The Perkin-Elmer Corp. | 1986-07-14 |
| WATERS 740 DATA MODULE-PLOTTER INTEGRATOR (K850272) | Millipore Corp. | 1985-03-06 |
| WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D (K850359) | Millipore Corp. | 1985-03-05 |
| REPORTING INTEGRATOR 3392A (K833113) | Hewlett-Packard Co. | 1983-11-21 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S002) | Bio-Rad | 1996-03-01 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S001) | Bio-Rad | 1991-03-14 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032) | Bio-Rad | 1989-07-24 |