COLUMNS LIQUID CHROMATOGRAPHY DPM
FDA 510(k) clearance K905538 · decided 1991-01-25
Clearance details
- K-number
- K905538
- Device name
- COLUMNS LIQUID CHROMATOGRAPHY DPM
- Applicant
- Millpore Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-12-11
- Decision date
- 1991-01-25
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- KZR
- 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 |
|---|---|---|
| 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR (K973074) | Waters Corporation | 1997-10-06 |
| USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 (K931227) | U.S. Drug Testing, Inc. | 1993-05-06 |
| SYVA SOLID PHASE COLUMNS SYSTEM II (K861392) | Syva Co. | 1986-06-13 |
| SERIES 410 LC PUMP (K860197) | The Perkin-Elmer Corp. | 1986-03-17 |
| VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM (K851945) | Varian Assoc., Inc. | 1985-05-24 |
| LIQUID CHROMATOGRAPH 400 (K843568) | The Perkin-Elmer Corp. | 1984-11-20 |
| VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY (K841890) | Varian Assoc., Inc. | 1984-06-14 |
| LIQUID CHROMATOGRAPHIC DETECTOR LC-95 (K840977) | The Perkin-Elmer Corp. | 1984-04-19 |
| CHROM-PREP (K832201) | Hamilton Co. | 1983-08-16 |
| VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS (K802725) | Varian Assoc., Inc. | 1980-12-11 |
| LIQUID CHROMATOGRAPH MODEL 850 (K780944) | E.I. Dupont DE Nemours & Co., Inc. | 1978-07-27 |
| LIQUID CHROMATOGRAPH MODEL 860 (K780945) | E.I. Dupont DE Nemours & Co., Inc. | 1978-07-27 |
Recalls involving this device
No recalls on record reference this clearance.