WATERS(TM) 996 PDA
FDA 510(k) clearance K924347 · decided 1992-12-11
Clearance details
- K-number
- K924347
- Device name
- WATERS(TM) 996 PDA
- Applicant
- Millipore Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-27
- Decision date
- 1992-12-11
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- KIE
- Device class
- 1
- Regulation number
- 862.2260
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Milford, MA, 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 |
|---|---|---|
| WATERS 515 HPLC PUMP (515) (K964588) | Waters Corporation | 1996-11-29 |
| PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP (K935666) | The Perkin-Elmer Corp. | 1994-04-26 |
| CHROMATOGRAPHY CLINICAL USE 75JQR (K914841) | Millipore Corp. | 1991-12-10 |
| EQUIPMENT/MATERIAL DECONTAMINATING KIT (K911299) | Rohm and Haas Co. | 1991-04-08 |
| THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR (K862506) | Millipore Corp. | 1986-07-29 |
| EMIT ANCILLARY REAGENTS (K844947) | Syva Co. | 1985-06-28 |
| SYVA SAMPLE SEAL (K844949) | Syva Co. | 1985-02-15 |
| DIFFERENTIAL REFRACTIVE INDEX DETECTOR (K800556) | Hewlett-Packard Co. | 1980-03-25 |
| DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM. (K800516) | E.I. Dupont DE Nemours & Co., Inc. | 1980-03-19 |
| LDC SPECTROMONITOR III (K800289) | Laboratory Data Control | 1980-02-26 |
| LDC CHROMATOGRAPHY ACCESSORY MODULE B (K800046) | Laboratory Data Control | 1980-02-25 |
| LDC CONSTAMETRIC III HIGHT PRESS. SOL. (K800048) | Laboratory Data Control | 1980-01-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THERAPEUTIC APHERESIS SYSTEM (P850092) | Millipore Corp. | 1986-11-18 |