Cardiac Troponin-I (Trop) Calibrator
FDA 510(k) K973668 · Dade Intl., Inc.
510(k) numberK973668
Submission
- Device name
- Cardiac Troponin-I (Trop) Calibrator
- Applicant
- Dade Intl., Inc.
Newark, DE, US - Received
- September 25, 1997
- Decision date
- October 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Cardiac Troponin-I (Trop) Calibrator cleared by the FDA?
Cardiac Troponin-I (Trop) Calibrator (K973668) received a 510(k) decision of Substantially Equivalent on October 20, 1997, 25 days after the submission was received.
What is the product code of K973668?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.