Stratus TDM Control, Levels I,Ii,Iii
FDA 510(k) K820296 · American Dade
510(k) numberK820296
Submission
- Device name
- Stratus TDM Control, Levels I,Ii,Iii
- Applicant
- American Dade
Mchenry, IL, US - Received
- February 4, 1982
- Decision date
- May 14, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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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| K872789 | Paramax Urine/Csf CalibratorJIX · Traditional | 09/02/1987SE |
| K872195 | Data-Fi Dimertest Latex AssayDAP · Traditional | 08/06/1987SE |
| K872196 | Aqueous Blood Gas/Electrolyte Contr Lev I,Ii & IIIJJS · Traditional | 07/31/1987SE |
| K871972 | Stratus Ige Fluorometric Enzyme ImmunoassayDGE · Traditional | 07/21/1987SE |
| K871977 | Dade Moni-Trol Chemistry Control/CalibratorJJY · Traditional | 07/09/1987SE |
| K872050 | Paramax Cholesterol ReagentLBS · Traditional | 07/07/1987SE |
| K872360 | Data-Fi Fibrin(Ogen) Degradation Prod.(Fdp)Det SetGHH · Traditional | 07/06/1987SE |
Questions and answers
When was Stratus TDM Control, Levels I,Ii,Iii cleared by the FDA?
Stratus TDM Control, Levels I,Ii,Iii (K820296) received a 510(k) decision of Substantially Equivalent on May 14, 1982, 99 days after the submission was received.
What is the product code of K820296?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.