Architect T-Uptake Calibrators (A-F) and Controls (Low, High)
FDA 510(k) K042307 · Seradyn, Inc.
510(k) numberK042307
Submission
- Device name
- Architect T-Uptake Calibrators (A-F) and Controls (Low, High)
- Applicant
- Seradyn, Inc.
Indianapolis, IN, US - Received
- August 25, 2004
- Decision date
- November 3, 2004
- 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 Architect T-Uptake Calibrators (A-F) and Controls (Low, High) cleared by the FDA?
Architect T-Uptake Calibrators (A-F) and Controls (Low, High) (K042307) received a 510(k) decision of Substantially Equivalent on November 3, 2004, 70 days after the submission was received.
What is the product code of K042307?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.