Clinical Chemistry Quality Control Material
FDA 510(k) K905457 · Consolidated Technologies, Inc.
510(k) numberK905457
Submission
- Device name
- Clinical Chemistry Quality Control Material
- Applicant
- Consolidated Technologies, Inc.
Austin, TX, US - Received
- December 5, 1990
- Decision date
- April 16, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DIF – Drug Mixture Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153474 | Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine…DIF · Traditional | Biochemical Diagnostics, Inc. | 02/23/2016SE |
| K132688 | Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, Au/NzDIF · Traditional | Biochemical Diagnostics, Inc. | 12/16/2013SE |
| K132174 | Multichem WBTDIF · Abbreviated | Techno-Path Manufacturing , Ltd. | 09/20/2013SE |
| K121122 | Detectabuse Liquid Control, Detectabuse Stat-Skreen Liquid ControlDIF · Traditional | Biochemical Diagnostic, Inc. | 07/03/2012SE |
| K121143 | Liquichek Whole Blood Immunosuppressant Control Tilevel (1,2 and 3)DIF · Traditional | Bio-Rad Laboratories | 05/18/2012SE |
| K120504 | Liquichek Urine Toxicology Control, S10 & S10 Minipak, Liquichek Urine Toxicology…DIF · Traditional | Bio-Rad Laboratories, Inc. | 03/27/2012SE |
| K103656 | Thermo Scientific Mas R Doa TotalDIF · Traditional | Microgenics Corporation | 03/24/2011SE |
| K093577 | Liquichek Opiate ControlDIF · Traditional | Bio-Rad Laboratories | 03/12/2010SE |
| K080085 | Mas Tox ControlDIF · Traditional | Thermo Fisher Scientific | 04/30/2008SE |
| K080183 | Control Set Dat I, Contrl Set Dat II, Control Set Dat III, Control Set Amphetamine 1000…DIF · Abbreviated | Roche Diagnostics Corp. | 03/25/2008SE |
More from Roche Diagnostics Corp.
| 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 Clinical Chemistry Quality Control Material cleared by the FDA?
Clinical Chemistry Quality Control Material (K905457) received a 510(k) decision of Substantially Equivalent on April 16, 1991, 132 days after the submission was received.
What is the product code of K905457?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.