Benzodiazepine Calibrator Set, Benzodiazepine Control Level 1, and Benzodiazepine Control Level 2
FDA 510(k) K132090 · Randox Laboratories, Ltd.
510(k) numberK132090
Submission
- Device name
- Benzodiazepine Calibrator Set, Benzodiazepine Control Level 1, and Benzodiazepine Control Level 2
- Applicant
- Randox Laboratories, Ltd.
Crumlin, GB - Received
- July 12, 2013
- Decision date
- August 8, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DLJ – Calibrators, Drug Specific
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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Questions and answers
When was Benzodiazepine Calibrator Set, Benzodiazepine Control Level 1, and Benzodiazepine Control Level 2 cleared by the FDA?
Benzodiazepine Calibrator Set, Benzodiazepine Control Level 1, and Benzodiazepine Control Level 2 (K132090) received a 510(k) decision of Substantially Equivalent on August 8, 2013, 27 days after the submission was received.
What is the product code of K132090?
The FDA product code is DLJ – Calibrators, Drug Specific, a Class II (moderate risk) device regulated under 21 CFR 862.3200.