Trace Transferrin Reagent
FDA 510(k) K932713 · Trace Scientific , Ltd.
510(k) numberK932713
Submission
- Device name
- Trace Transferrin Reagent
- Applicant
- Trace Scientific , Ltd.
Clayton, Vic 3168, AU - Received
- June 4, 1993
- Decision date
- September 30, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DDQ – Antigen, Antiserum, Control, Antithrombin Iii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7060
- Specialty
- Hematology
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|---|---|---|---|
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| K935307 | Dade(R) Thrombin-Antithrombin (Tat) Complex ElisaDDQ · Traditional | Baxter Diagnostics, Inc. | 11/22/1994SE |
| K780012 | Antithrombin III RiaDDQ · Traditional | Ria Diagnostics | 01/20/1978SE |
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Questions and answers
When was Trace Transferrin Reagent cleared by the FDA?
Trace Transferrin Reagent (K932713) received a 510(k) decision of Substantially Equivalent on September 30, 1993, 118 days after the submission was received.
What is the product code of K932713?
The FDA product code is DDQ – Antigen, Antiserum, Control, Antithrombin Iii, a Class II (moderate risk) device regulated under 21 CFR 864.7060.