510(k) K911299
- Device
- EQUIPMENT/MATERIAL DECONTAMINATING KIT
- Applicant
- ROHM AND HAAS CO.
- 510(k) number
- K911299
- Product code
- KIE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-04-08
- Date received
- 1991-03-25
- Regulation
- 862.2260
- Classification name
- Apparatus, High Pressure Liquid Chromatography
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PETER O SAFIR
- Address
- C/O Kleinfeld, Kaplan & Becker 1140 Nineteenth St., NW Washington DC US 20036 20036
FDA Registration Numbers#
- 3003423869
- 3009715051
- 3008336863
- 1218959
- 3006397327
- 3009202467
- 3003809634
- 3001040364
- 2916205
- 3010607747
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KIE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K964588 | WATERS 515 HPLC PUMP (515) | Waters Corporation | 1996-11-29 |
| K935666 | PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP | The Perkin-Elmer Corp. | 1994-04-26 |
| K924347 | WATERS(TM) 996 PDA | Millipore Corp. | 1992-12-11 |
| K914841 | CHROMATOGRAPHY CLINICAL USE 75JQR | Millipore Corp. | 1991-12-10 |
| K862506 | THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR | Millipore Corp. | 1986-07-29 |
| K844947 | EMIT ANCILLARY REAGENTS | Syva Co. | 1985-06-28 |
| K844949 | SYVA SAMPLE SEAL | Syva Co. | 1985-02-15 |
| K800556 | DIFFERENTIAL REFRACTIVE INDEX DETECTOR | Hewlett-Packard Co. | 1980-03-25 |
| K800516 | DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM. | E.I. Dupont DE Nemours & Co., Inc. | 1980-03-19 |
| K800289 | LDC SPECTROMONITOR III | Laboratory Data Control | 1980-02-26 |
| K800046 | LDC CHROMATOGRAPHY ACCESSORY MODULE B | Laboratory Data Control | 1980-02-25 |
| K800048 | LDC CONSTAMETRIC III HIGHT PRESS. SOL. | Laboratory Data Control | 1980-01-29 |
| K800047 | LDC UVIII FIXED WAVELENGTH ULTRAVIOLET | Laboratory Data Control | 1980-01-21 |
| K791661 | SYSTEM CONTROLLER 720 SERIES | Waters Assoc., Inc. | 1979-09-24 |
| K790145 | SOLVENT DELIVERY SYSTEM | Waters Assoc., Inc. | 1979-02-15 |
Legacy Summary#
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FDA Review#
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