Lyphochek Benzo/Tca Control Serum, Levels 1 and 2
FDA 510(k) K910829 · Bio-Rad
510(k) numberK910829
Submission
- Device name
- Lyphochek Benzo/Tca Control Serum, Levels 1 and 2
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- February 27, 1991
- Decision date
- April 3, 1991
- 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 Lyphochek Benzo/Tca Control Serum, Levels 1 and 2 cleared by the FDA?
Lyphochek Benzo/Tca Control Serum, Levels 1 and 2 (K910829) received a 510(k) decision of Substantially Equivalent on April 3, 1991, 35 days after the submission was received.
What is the product code of K910829?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.