Free T3 Calibrators on the Access Immunoassay Systems
FDA 510(k) K042651 · Beckman Coulter, Inc.
510(k) numberK042651
Submission
- Device name
- Free T3 Calibrators on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- September 28, 2004
- Decision date
- October 5, 2004
- 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 Free T3 Calibrators on the Access Immunoassay Systems cleared by the FDA?
Free T3 Calibrators on the Access Immunoassay Systems (K042651) received a 510(k) decision of Substantially Equivalent on October 5, 2004, 7 days after the submission was received.
What is the product code of K042651?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.