Usdt Flow Immunoassay System, Model 9000
FDA 510(k) K931227 · U.S. Drug Testing, Inc.
510(k) numberK931227
Submission
- Device name
- Usdt Flow Immunoassay System, Model 9000
- Applicant
- U.S. Drug Testing, Inc.
Rancho Cucamonga, CA, US - Received
- March 10, 1993
- Decision date
- May 6, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KZR – Chromatography (Liquid, Gel), Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2260
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KZR
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|---|---|---|---|
| K973074 | 2487 Dual Wavelength Absorbance DetectorKZR · Traditional | Waters Corporation | 10/06/1997SE |
| K905538 | Columns Liquid Chromatography DPMKZR · Traditional | Millpore Corp. | 01/25/1991SE |
| K861392 | Syva Solid Phase Columns System IIKZR · Traditional | Syva Co. | 06/13/1986SE |
| K860197 | Series 410 LC PumpKZR · Traditional | The Perkin-Elmer Corp. | 03/17/1986SE |
| K851945 | Varian Aasp Automated Sample Prep. SystemKZR · Traditional | Varian Assoc., Inc. | 05/24/1985SE |
| K843568 | Liquid Chromatograph 400KZR · Traditional | The Perkin-Elmer Corp. | 11/20/1984SE |
| K841890 | Varian 2000 Liquid Chromatography AnalyKZR · Traditional | Varian Assoc., Inc. | 06/14/1984SE |
| K840977 | Liquid Chromatographic Detector LC-95KZR · Traditional | The Perkin-Elmer Corp. | 04/19/1984SE |
| K832201 | Chrom-PrepKZR · Traditional | Hamilton Co. | 08/16/1983SE |
| K802725 | Vista 54 Liquid Chromatography Anal. SysKZR · Traditional | Varian Assoc., Inc. | 12/11/1980SE |
More from Varian Assoc., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940912 | Usdt Cannabinoid (THC) Assay Column Catalog No. 9000-500LDJ · Traditional | 06/02/1994SE |
| K935629 | Usdt Phencyclidine (PCP) Assay Column Cat. No. 9000-400LCM · Traditional | 04/12/1994SE |
| K934693 | Amphetamine Test SystemDKZ · Traditional | 11/22/1993SE |
| K932318 | Usdt Opiate Assay Column Catalog No. 9000-200DJG · Traditional | 06/15/1993SE |
| K930985 | Usdt Cocaine/Cocaine Metabol Assay COLUMN,9000-100DIO · Traditional | 04/27/1993SE |
Questions and answers
When was Usdt Flow Immunoassay System, Model 9000 cleared by the FDA?
Usdt Flow Immunoassay System, Model 9000 (K931227) received a 510(k) decision of Substantially Equivalent on May 6, 1993, 57 days after the submission was received.
What is the product code of K931227?
The FDA product code is KZR – Chromatography (Liquid, Gel), Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2260.