Ethyl Alcohol Clinical Standard Solutions
FDA 510(k) K981926 · Emd Chemicals, Inc.
510(k) numberK981926
Submission
- Device name
- Ethyl Alcohol Clinical Standard Solutions
- Applicant
- Emd Chemicals, Inc.
Gibbstown, NJ, US - Received
- June 2, 1998
- Decision date
- July 22, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DLJ – Calibrators, Drug Specific
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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Questions and answers
When was Ethyl Alcohol Clinical Standard Solutions cleared by the FDA?
Ethyl Alcohol Clinical Standard Solutions (K981926) received a 510(k) decision of Substantially Equivalent on July 22, 1998, 50 days after the submission was received.
What is the product code of K981926?
The FDA product code is DLJ – Calibrators, Drug Specific, a Class II (moderate risk) device regulated under 21 CFR 862.3200.