Dc-Aceta/Sal Controls
FDA 510(k) K041666 · Diagnostic Chemicals , Ltd.
510(k) numberK041666
Submission
- Device name
- Dc-Aceta/Sal Controls
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, Prince Edward, CA - Received
- June 18, 2004
- Decision date
- August 17, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K070383 | Enzymatic Creatinine Assay (265 Series)JFY · Traditional | 06/22/2007SE |
| K063208 | Magnesium Assay (XB), Models 125-12, 125-50 and 125-S7JGJ · Traditional | 01/19/2007SE |
| K060139 | Crp-Advance Assay, Models 250-20, 250-25DCK · Traditional | 04/28/2006SE |
| K060140 | Crp-Advance Multi Calibrator Set, Model SE-250JIT · Traditional | 04/24/2006SE |
| K051757 | Calcium Advance Assay, Model 145-20, 145-25, 145-20-91CJY · Traditional | 11/10/2005SE |
| K051191 | DCL Microalbumin Assay, Model 252-20DCF · Traditional | 07/05/2005SE |
| K042330 | Acetaminophen-Sl AssayLDP · Traditional | 01/07/2005SE |
| K042362 | Modification to Carbon DIOXIDE-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and…KHS · Traditional | 12/27/2004SE |
| K042329 | Salicylate-Sl AssayDKJ · Traditional | 12/27/2004SE |
| K041928 | Hdl-Advance Assay, Cat. No. 278-20, 278-50A, 278-50BLBS · Traditional | 11/23/2004SE |
Questions and answers
When was Dc-Aceta/Sal Controls cleared by the FDA?
Dc-Aceta/Sal Controls (K041666) received a 510(k) decision of Substantially Equivalent on August 17, 2004, 60 days after the submission was received.
What is the product code of K041666?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.