Ethyl Alcohol Clinical Standard Solutions
FDA 510(k) K990516 · Emd Chemicals, Inc.
510(k) numberK990516
Submission
- Device name
- Ethyl Alcohol Clinical Standard Solutions
- Applicant
- Emd Chemicals, Inc.
Gibbstown, NJ, US - Received
- February 18, 1999
- Decision date
- March 31, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
| K802620 | Emit-Stm Ethyl Alcohol Urine CalibratorDNN · Traditional | Syva Co. | 10/31/1980SE |
More from Syva Co.
| 510(k) | Device | Decision |
|---|---|---|
| K031367 | Duopath Verotoxins Glisa TestGNA · Traditional | 01/23/2004SE |
| K981926 | Ethyl Alcohol Clinical Standard SolutionsDLJ · Traditional | 07/22/1998SE |
| K973054 | Ethyl Alcohol Clinical Standard SolutionsDNN · Traditional | 10/01/1997SE |
| K951494 | Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR)CIJ · Traditional | 12/11/1995SE |
| K951750 | Glucose Test Item Number 97375/94LFR · Traditional | 09/06/1995SE |
| K950234 | Total Protein Test (Tpro) Item Number: XXXXX/R1. R2CEK · Traditional | 06/14/1995SE |
| K950128 | Total Protein Test (Tpro) Item XXXXX/R1. R2CEK · Traditional | 05/15/1995SE |
| K945322 | Phosphorus Test (Phos) Item Number 65416CEO · Traditional | 12/07/1994SE |
| K945368 | Phosphorus Test (Phos)CEO · Traditional | 12/02/1994SE |
| K840883 | Unipak 100 Analyzer, 65156 & ChemistrJJE · Traditional | 05/16/1984SE |
Questions and answers
When was Ethyl Alcohol Clinical Standard Solutions cleared by the FDA?
Ethyl Alcohol Clinical Standard Solutions (K990516) received a 510(k) decision of Substantially Equivalent on March 31, 1999, 41 days after the submission was received.
What is the product code of K990516?
The FDA product code is DNN – Calibrators, Ethyl Alcohol, a Class II (moderate risk) device regulated under 21 CFR 862.3200.