Modification to Quantimetrix Urine Drugs of Abuse Control
FDA 510(k) K060417 · Quantimetrix Corp.
510(k) numberK060417
Submission
- Device name
- Modification to Quantimetrix Urine Drugs of Abuse Control
- Applicant
- Quantimetrix Corp.
Redondo Beach, CA, US - Received
- February 17, 2006
- Decision date
- March 21, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K132174 | Multichem WBTDIF · Abbreviated | Techno-Path Manufacturing , Ltd. | 09/20/2013SE |
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| 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 |
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Questions and answers
When was Modification to Quantimetrix Urine Drugs of Abuse Control cleared by the FDA?
Modification to Quantimetrix Urine Drugs of Abuse Control (K060417) received a 510(k) decision of Substantially Equivalent on March 21, 2006, 32 days after the submission was received.
What is the product code of K060417?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.