Sigma Procedure No. 333-UV
FDA 510(k) K914777 · Sigma Diagnostics, Inc.
510(k) numberK914777
Submission
- Device name
- Sigma Procedure No. 333-UV
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- October 23, 1991
- Decision date
- December 27, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DML – Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3040
- Specialty
- Clinical Toxicology
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Questions and answers
When was Sigma Procedure No. 333-UV cleared by the FDA?
Sigma Procedure No. 333-UV (K914777) received a 510(k) decision of Substantially Equivalent on December 27, 1991, 65 days after the submission was received.
What is the product code of K914777?
The FDA product code is DML – Nad-Nadh, Specific Reagent For Alcohol Enzyme Method, a Class II (moderate risk) device regulated under 21 CFR 862.3040.