Carbamazepine Assay for the Technicon Immuno 1 System
FDA 510(k) K964068 · Bayer Corp.
510(k) numberK964068
Submission
- Device name
- Carbamazepine Assay for the Technicon Immuno 1 System
- Applicant
- Bayer Corp.
Tarrytown, NY, US - Received
- October 10, 1996
- Decision date
- December 13, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KLT – Enzyme Immunoassay, Carbamazepine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3645
- Specialty
- Clinical Toxicology
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Questions and answers
When was Carbamazepine Assay for the Technicon Immuno 1 System cleared by the FDA?
Carbamazepine Assay for the Technicon Immuno 1 System (K964068) received a 510(k) decision of Substantially Equivalent on December 13, 1996, 64 days after the submission was received.
What is the product code of K964068?
The FDA product code is KLT – Enzyme Immunoassay, Carbamazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3645.