Liquichek Urine Toxicology Control, S10 & S10 Minipak, Liquichek Urine Toxicology Control, Level S20 & Level S20 Minipak
FDA 510(k) K120504 · Bio-Rad Laboratories, Inc.
510(k) numberK120504
Submission
- Device name
- Liquichek Urine Toxicology Control, S10 & S10 Minipak, Liquichek Urine Toxicology Control, Level S20 & Level S20 Minipak
- Applicant
- Bio-Rad Laboratories, Inc.
Irvine, CA, US - Received
- February 21, 2012
- Decision date
- March 27, 2012
- 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, S10 & S10 Minipak, Liquichek Urine Toxicology Control, Level S20 & Level S20 Minipak cleared by the FDA?
Liquichek Urine Toxicology Control, S10 & S10 Minipak, Liquichek Urine Toxicology Control, Level S20 & Level S20 Minipak (K120504) received a 510(k) decision of Substantially Equivalent on March 27, 2012, 35 days after the submission was received.
What is the product code of K120504?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.