Dimension Vista System Drugs of Abuse Positive and Negative Controls, Models KC515 and KC516
FDA 510(k) K062191 · Dade Behring, Inc.
510(k) numberK062191
Submission
- Device name
- Dimension Vista System Drugs of Abuse Positive and Negative Controls, Models KC515 and KC516
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- July 31, 2006
- Decision date
- August 21, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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| 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 |
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| 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 |
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Questions and answers
When was Dimension Vista System Drugs of Abuse Positive and Negative Controls, Models KC515 and KC516 cleared by the FDA?
Dimension Vista System Drugs of Abuse Positive and Negative Controls, Models KC515 and KC516 (K062191) received a 510(k) decision of Substantially Equivalent on August 21, 2006, 21 days after the submission was received.
What is the product code of K062191?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.