Tdx(R) Barbiturates II Assay
FDA 510(k) K896550 · Abbott Laboratories
510(k) numberK896550
Submission
- Device name
- Tdx(R) Barbiturates II Assay
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- November 17, 1989
- Decision date
- December 19, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DIS – Enzyme Immunoassay, Barbiturate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3150
- Specialty
- Clinical Toxicology
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Questions and answers
When was Tdx(R) Barbiturates II Assay cleared by the FDA?
Tdx(R) Barbiturates II Assay (K896550) received a 510(k) decision of Substantially Equivalent on December 19, 1989, 32 days after the submission was received.
What is the product code of K896550?
The FDA product code is DIS – Enzyme Immunoassay, Barbiturate, a Class II (moderate risk) device regulated under 21 CFR 862.3150.