Emit-Stm Ethyl Alcohol Urine Calibrator
FDA 510(k) K802620 · Syva Co.
510(k) numberK802620
Submission
- Device name
- Emit-Stm Ethyl Alcohol Urine Calibrator
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- October 20, 1980
- Decision date
- October 31, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DNN – Calibrators, Ethyl Alcohol
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DNN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990516 | Ethyl Alcohol Clinical Standard SolutionsDNN · Traditional | Emd Chemicals, Inc. | 03/31/1999SE |
| K973054 | Ethyl Alcohol Clinical Standard SolutionsDNN · Traditional | Emd Chemicals, Inc. | 10/01/1997SE |
| K924733 | Ethyl Alcohol Calibrators & ControlDNN · Traditional | Diagnostic Reagents, Inc. | 12/09/1992SE |
| K882117 | Ethyl Alcohol StandardDNN · Traditional | Verichem Laboratories, Inc. | 08/04/1988SE |
| K853532 | Alcohol CalibratorsDNN · Traditional | Diagnostic Systems | 09/16/1985SE |
| K810466 | Ethyl Alcohol Serum CalibratorDNN · Traditional | Syva Co. | 03/06/1981SE |
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| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | 02/01/2000SE |
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Questions and answers
When was Emit-Stm Ethyl Alcohol Urine Calibrator cleared by the FDA?
Emit-Stm Ethyl Alcohol Urine Calibrator (K802620) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 11 days after the submission was received.
What is the product code of K802620?
The FDA product code is DNN – Calibrators, Ethyl Alcohol, a Class II (moderate risk) device regulated under 21 CFR 862.3200.