Control Set Dat I, Contrl Set Dat II, Control Set Dat III, Control Set Amphetamine 1000 and Control Set Amphetamine 500
FDA 510(k) K080183 · Roche Diagnostics Corp.
510(k) numberK080183
Submission
- Device name
- Control Set Dat I, Contrl Set Dat II, Control Set Dat III, Control Set Amphetamine 1000 and Control Set Amphetamine 500
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- January 25, 2008
- Decision date
- March 25, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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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| K080085 | Mas Tox ControlDIF · Traditional | Thermo Fisher Scientific | 04/30/2008SE |
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Questions and answers
When was Control Set Dat I, Contrl Set Dat II, Control Set Dat III, Control Set Amphetamine 1000 and Control Set Amphetamine 500 cleared by the FDA?
Control Set Dat I, Contrl Set Dat II, Control Set Dat III, Control Set Amphetamine 1000 and Control Set Amphetamine 500 (K080183) received a 510(k) decision of Substantially Equivalent on March 25, 2008, 60 days after the submission was received.
What is the product code of K080183?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.