510(k) K973074
- Device
- 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR
- Applicant
- WATERS CORPORATION
- 510(k) number
- K973074
- Product code
- KZR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-10-06
- Date received
- 1997-08-18
- Regulation
- 862.2260
- Classification name
- Chromatography (liquid, Gel), Clinical Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- VIRGINIA L CORBIN
- Address
- 34 Maple St. Milford MA US 01757 01757
FDA Registration Numbers#
- 3038624837
- 3003951180
- 3014150341
- 3033858895
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KZR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K931227 | USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 | U.S. Drug Testing, Inc. | 1993-05-06 |
| K905538 | COLUMNS LIQUID CHROMATOGRAPHY DPM | Millpore Corp. | 1991-01-25 |
| K861392 | SYVA SOLID PHASE COLUMNS SYSTEM II | Syva Co. | 1986-06-13 |
| K860197 | SERIES 410 LC PUMP | The Perkin-Elmer Corp. | 1986-03-17 |
| K851945 | VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM | Varian Assoc., Inc. | 1985-05-24 |
| K843568 | LIQUID CHROMATOGRAPH 400 | The Perkin-Elmer Corp. | 1984-11-20 |
| K841890 | VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY | Varian Assoc., Inc. | 1984-06-14 |
| K840977 | LIQUID CHROMATOGRAPHIC DETECTOR LC-95 | The Perkin-Elmer Corp. | 1984-04-19 |
| K832201 | CHROM-PREP | Hamilton Co. | 1983-08-16 |
| K802725 | VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS | Varian Assoc., Inc. | 1980-12-11 |
| K780944 | LIQUID CHROMATOGRAPH MODEL 850 | E.I. Dupont DE Nemours & Co., Inc. | 1978-07-27 |
| K780945 | LIQUID CHROMATOGRAPH MODEL 860 | E.I. Dupont DE Nemours & Co., Inc. | 1978-07-27 |
| K770255 | LC-65T DETECTOR AND OVEN | The Perkin-Elmer Corp. | 1977-02-25 |
| K770254 | CHROMATOGRAPH, SERIES 3, LIQUID | The Perkin-Elmer Corp. | 1977-02-24 |
Legacy Summary#
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FDA Review#
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