Liquichek Urine Toxicology Control (Screen Series)
FDA 510(k) K033924 · Bio-Rad Laboratories, Inc.
510(k) numberK033924
Submission
- Device name
- Liquichek Urine Toxicology Control (Screen Series)
- Applicant
- Bio-Rad Laboratories, Inc.
Irvine, CA, US - Received
- December 18, 2003
- Decision date
- February 3, 2004
- 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 Liquichek Urine Toxicology Control (Screen Series) cleared by the FDA?
Liquichek Urine Toxicology Control (Screen Series) (K033924) received a 510(k) decision of Substantially Equivalent on February 3, 2004, 47 days after the submission was received.
What is the product code of K033924?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.