ADVANCED PURIFICATION GLASS COLUMN
FDA 510(k) clearance K891673 · decided 1989-04-26
Clearance details
- K-number
- K891673
- Device name
- ADVANCED PURIFICATION GLASS COLUMN
- Applicant
- Waters Chemical Products
- Decision
- Substantially Equivalent
- Date received
- 1989-03-21
- Decision date
- 1989-04-26
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- DPM
- 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 |
|---|---|---|
| TOX PERFECT B TUBES AND REAGENTS (K952501) | Chimera Research & Chemical, Inc. | 1995-08-24 |
| HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE (K895105) | Waters Chemical Products | 1989-10-06 |
| LIQUID CHROMATOGRAPHY COLUMNS (K894141) | Supelco, Inc. | 1989-08-21 |
| LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE (K884403) | Supelco, Inc. | 1988-12-22 |
| LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD (K881868) | Supelco, Inc. | 1988-08-29 |
| LIQUID CHROMATO. COLUMNS (K880724) | Supelco, Inc. | 1988-05-27 |
| SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY) (K864267) | Millipore Corp. | 1987-01-09 |
| LIQUID CHROMATOGRAPHY COLUMNS (K862541) | Supelco, Inc. | 1986-07-29 |
| LIQUID CHROMATOGRAPHY COLUMNS (K861633) | Supelco, Inc. | 1986-05-23 |
| LIQUID CHROMATOGRAPHY COLUMNS;ION EXCH (K842909) | Supelco, Inc. | 1984-10-05 |
| PRP-1 REVERSED PHASE COLUMNS FOR HPLC (K832200) | Hamilton Co. | 1983-08-16 |
| LIQUID CHROMATOGRAPHY (HPLC) COLUMNS (K813575) | Supelco, Inc. | 1982-01-18 |
Recalls involving this device
No recalls on record reference this clearance.