Therachem, TDC Therapeutic Drug Controls
FDA 510(k) K860919 · Fisher Scientific Co., LLC
510(k) numberK860919
Submission
- Device name
- Therachem, TDC Therapeutic Drug Controls
- Applicant
- Fisher Scientific Co., LLC
Orangeburg, NY, US - Received
- March 11, 1986
- Decision date
- April 11, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Therachem, TDC Therapeutic Drug Controls cleared by the FDA?
Therachem, TDC Therapeutic Drug Controls (K860919) received a 510(k) decision of Substantially Equivalent on April 11, 1986, 31 days after the submission was received.
What is the product code of K860919?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.