Phenytoin Fpia Controls
FDA 510(k) K871567 · Sigma Diagnostics, Inc.
510(k) numberK871567
Submission
- Device name
- Phenytoin Fpia Controls
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- April 22, 1987
- Decision date
- July 1, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LAS – Drug Specific Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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Questions and answers
When was Phenytoin Fpia Controls cleared by the FDA?
Phenytoin Fpia Controls (K871567) received a 510(k) decision of Substantially Equivalent on July 1, 1987, 70 days after the submission was received.
What is the product code of K871567?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.