Cobas C Acetaminophen GEN.2 Assay, ACET2 Calibrator
FDA 510(k) K141928 · Roche Diagnostics Operations (Rdo)
510(k) numberK141928
Submission
- Device name
- Cobas C Acetaminophen GEN.2 Assay, ACET2 Calibrator
- Applicant
- Roche Diagnostics Operations (Rdo)
Indianapolis, IN, US - Received
- July 16, 2014
- Decision date
- November 25, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKB – Calibrators, Drug Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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Questions and answers
When was Cobas C Acetaminophen GEN.2 Assay, ACET2 Calibrator cleared by the FDA?
Cobas C Acetaminophen GEN.2 Assay, ACET2 Calibrator (K141928) received a 510(k) decision of Substantially Equivalent on November 25, 2014, 132 days after the submission was received.
What is the product code of K141928?
The FDA product code is DKB – Calibrators, Drug Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.3200.