TDM I Linearity Test Set
FDA 510(k) K913309 · Casco Standards
510(k) numberK913309
Submission
- Device name
- TDM I Linearity Test Set
- Applicant
- Casco Standards
Yarmouth, ME, US - Received
- July 25, 1991
- Decision date
- September 13, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 TDM I Linearity Test Set cleared by the FDA?
TDM I Linearity Test Set (K913309) received a 510(k) decision of Substantially Equivalent on September 13, 1991, 50 days after the submission was received.
What is the product code of K913309?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.