Esa Leadcare II Lead Control
FDA 510(k) K063398 · Bionostics, Inc.
510(k) numberK063398
Submission
- Device name
- Esa Leadcare II Lead Control
- Applicant
- Bionostics, Inc.
Devens, MA, US - Received
- November 9, 2006
- Decision date
- December 5, 2006
- 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 Esa Leadcare II Lead Control cleared by the FDA?
Esa Leadcare II Lead Control (K063398) received a 510(k) decision of Substantially Equivalent on December 5, 2006, 26 days after the submission was received.
What is the product code of K063398?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.