Vigil TDM Controls
FDA 510(k) K972819 · Beckman Instruments, Inc.
510(k) numberK972819
Submission
- Device name
- Vigil TDM Controls
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- July 29, 1997
- Decision date
- August 13, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DIF – Drug Mixture 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 Vigil TDM Controls cleared by the FDA?
Vigil TDM Controls (K972819) received a 510(k) decision of Substantially Equivalent on August 13, 1997, 15 days after the submission was received.
What is the product code of K972819?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.