Document TDM Ultra Unassayed Control
FDA 510(k) K955155 · Casco Standards
510(k) numberK955155
Submission
- Device name
- Document TDM Ultra Unassayed Control
- Applicant
- Casco Standards
Yarmouth, ME, US - Received
- November 13, 1995
- Decision date
- December 20, 1995
- 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 Document TDM Ultra Unassayed Control cleared by the FDA?
Document TDM Ultra Unassayed Control (K955155) received a 510(k) decision of Substantially Equivalent on December 20, 1995, 37 days after the submission was received.
What is the product code of K955155?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.