Reference Material for Phencyclidine in Human Urine
FDA 510(k) K933557 · Consolidated Technologies, Inc.
510(k) numberK933557
Submission
- Device name
- Reference Material for Phencyclidine in Human Urine
- Applicant
- Consolidated Technologies, Inc.
Austin, TX, US - Received
- July 21, 1993
- Decision date
- September 10, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LAS – Drug Specific Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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| K971210 | Synchron Systems 10 Ng/Ml & 40 Ng/Ml THC Urine ControlsLAS · Traditional | Beckman Instruments, Inc. | 04/17/1997SE |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K000116 | Qualitrol Urinalysis with Microscopics Control, Levels 1,2 and 3JJY · Traditional | 02/15/2000SE |
| K992578 | Urine Chemistry Control, Level 2JJW · Traditional | 09/03/1999SE |
| K992576 | Urine Chemistry Control, Level 1JJW · Traditional | 09/03/1999SE |
| K992151 | Reference Material for DELTA-9-THC-COOH in Human UrineLAS · Traditional | 07/14/1999SE |
| K981339 | Quickcheck Lyophilized Chemistry Control Conformance Chemistry Control C3JJY · Traditional | 04/21/1998SE |
| K974699 | Reference Material for Amphetamine/Methamphetamine in Human UrineDKB · Traditional | 01/22/1998SE |
| K973469 | Quikcheck Unassayed Chemistry Control Levels 1 and 2, Conformancemccliquichem Unassayed…JJY · Traditional | 09/25/1997SE |
| K972146 | Qualitrol Unassayed H. Pylori Control Set Positive and Negative ControlsLYR · Traditional | 07/08/1997SE |
| K972080 | Qualitrol DHP Immunoassay Control Levels 1,2 and 3, Conformancee Mcc-Ligand Control…JJY · Traditional | 06/18/1997SE |
| K961815 | Qualitrol Ana Control Serum SetLKJ · Traditional | 09/27/1996SE |
Questions and answers
When was Reference Material for Phencyclidine in Human Urine cleared by the FDA?
Reference Material for Phencyclidine in Human Urine (K933557) received a 510(k) decision of Substantially Equivalent on September 10, 1993, 51 days after the submission was received.
What is the product code of K933557?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.