Liquichek(R) Serum Alcohol Control; Levels 1,2 & 3
FDA 510(k) K892004 · Bio-Rad
510(k) numberK892004
Submission
- Device name
- Liquichek(R) Serum Alcohol Control; Levels 1,2 & 3
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- March 28, 1989
- Decision date
- April 21, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LAS – Drug Specific 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(R) Serum Alcohol Control; Levels 1,2 & 3 cleared by the FDA?
Liquichek(R) Serum Alcohol Control; Levels 1,2 & 3 (K892004) received a 510(k) decision of Substantially Equivalent on April 21, 1989, 24 days after the submission was received.
What is the product code of K892004?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.