Diazyme Homocysteine Assay Buffer Based Calibrators
FDA 510(k) K102638 · Diazyme Laboratories
510(k) numberK102638
Submission
- Device name
- Diazyme Homocysteine Assay Buffer Based Calibrators
- Applicant
- Diazyme Laboratories
Poway, CA, US - Received
- September 14, 2010
- Decision date
- November 30, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Diazyme Homocysteine Assay Buffer Based Calibrators cleared by the FDA?
Diazyme Homocysteine Assay Buffer Based Calibrators (K102638) received a 510(k) decision of Substantially Equivalent on November 30, 2010, 77 days after the submission was received.
What is the product code of K102638?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.