Tri-Point, Liquimmune Liquid Assayed Immunoassay Control, Levels 1, 2, and 3
FDA 510(k) K993546 · Medical Analysis Systems, Inc.
510(k) numberK993546
Submission
- Device name
- Tri-Point, Liquimmune Liquid Assayed Immunoassay Control, Levels 1, 2, and 3
- Applicant
- Medical Analysis Systems, Inc.
Camarillo, CA, US - Received
- October 19, 1999
- Decision date
- November 30, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Tri-Point, Liquimmune Liquid Assayed Immunoassay Control, Levels 1, 2, and 3 cleared by the FDA?
Tri-Point, Liquimmune Liquid Assayed Immunoassay Control, Levels 1, 2, and 3 (K993546) received a 510(k) decision of Substantially Equivalent on November 30, 1999, 42 days after the submission was received.
What is the product code of K993546?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.