Liquichek Qualitative Urine Toxicology Control, Negative, Model 454; Positive, Model 455
FDA 510(k) K033366 · Bio-Rad
510(k) numberK033366
Submission
- Device name
- Liquichek Qualitative Urine Toxicology Control, Negative, Model 454; Positive, Model 455
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- October 21, 2003
- Decision date
- December 12, 2003
- 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 Qualitative Urine Toxicology Control, Negative, Model 454; Positive, Model 455 cleared by the FDA?
Liquichek Qualitative Urine Toxicology Control, Negative, Model 454; Positive, Model 455 (K033366) received a 510(k) decision of Substantially Equivalent on December 12, 2003, 52 days after the submission was received.
What is the product code of K033366?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.