Abbott Architect Stat Troponin I Liquid Assayed Cardiac Marker Control Level L, M and H
FDA 510(k) K041194 · Medical Analysis Systems, Inc.
510(k) numberK041194
Submission
- Device name
- Abbott Architect Stat Troponin I Liquid Assayed Cardiac Marker Control Level L, M and H
- Applicant
- Medical Analysis Systems, Inc.
Camarillo, CA, US - Received
- May 6, 2004
- Decision date
- August 16, 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 Abbott Architect Stat Troponin I Liquid Assayed Cardiac Marker Control Level L, M and H cleared by the FDA?
Abbott Architect Stat Troponin I Liquid Assayed Cardiac Marker Control Level L, M and H (K041194) received a 510(k) decision of Substantially Equivalent on August 16, 2004, 102 days after the submission was received.
What is the product code of K041194?
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.