Diazyme Lithium Enzymatic Assay Kit
FDA 510(k) K033360 · General Atomics
510(k) numberK033360
Submission
- Device name
- Diazyme Lithium Enzymatic Assay Kit
- Applicant
- General Atomics
San Diego, CA, US - Received
- October 21, 2003
- Decision date
- December 23, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JII – Atomic Absorption, Lithium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3560
- Specialty
- Clinical Toxicology
Other 510(k)s with product code JII
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Questions and answers
When was Diazyme Lithium Enzymatic Assay Kit cleared by the FDA?
Diazyme Lithium Enzymatic Assay Kit (K033360) received a 510(k) decision of Substantially Equivalent on December 23, 2003, 63 days after the submission was received.
What is the product code of K033360?
The FDA product code is JII – Atomic Absorption, Lithium, a Class II (moderate risk) device regulated under 21 CFR 862.3560.