Diazyme Homocysteine Enzymatic Assay Kit
FDA 510(k) K042448 · General Atomics
510(k) numberK042448
Submission
- Device name
- Diazyme Homocysteine Enzymatic Assay Kit
- Applicant
- General Atomics
San Diego, CA, US - Received
- September 9, 2004
- Decision date
- October 29, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Diazyme Homocysteine Enzymatic Assay Kit cleared by the FDA?
Diazyme Homocysteine Enzymatic Assay Kit (K042448) received a 510(k) decision of Substantially Equivalent on October 29, 2004, 50 days after the submission was received.
What is the product code of K042448?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.