Triage Tox Drug Screen Calibration Verification Controls, Catalog #94002
FDA 510(k) K013002 · Biosite Incorporated
510(k) numberK013002
Submission
- Device name
- Triage Tox Drug Screen Calibration Verification Controls, Catalog #94002
- Applicant
- Biosite Incorporated
San Diego, CA, US - Received
- September 6, 2001
- Decision date
- October 3, 2001
- 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 Triage Tox Drug Screen Calibration Verification Controls, Catalog #94002 cleared by the FDA?
Triage Tox Drug Screen Calibration Verification Controls, Catalog #94002 (K013002) received a 510(k) decision of Substantially Equivalent on October 3, 2001, 27 days after the submission was received.
What is the product code of K013002?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.