MGC Dau Control Sets: Primary, Clinical and Select
FDA 510(k) K040758 · Microgenics Corp.
510(k) numberK040758
Submission
- Device name
- MGC Dau Control Sets: Primary, Clinical and Select
- Applicant
- Microgenics Corp.
Fremont Blvd., CA, US - Received
- March 25, 2004
- Decision date
- May 28, 2004
- 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 MGC Dau Control Sets: Primary, Clinical and Select cleared by the FDA?
MGC Dau Control Sets: Primary, Clinical and Select (K040758) received a 510(k) decision of Substantially Equivalent on May 28, 2004, 64 days after the submission was received.
What is the product code of K040758?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.