N-Assay Tia Antithrombin III Test Kit
FDA 510(k) K972257 · Crestat Diagnostics, Inc.
510(k) numberK972257
Submission
- Device name
- N-Assay Tia Antithrombin III Test Kit
- Applicant
- Crestat Diagnostics, Inc.
Weston, CT, US - Received
- June 17, 1997
- Decision date
- October 20, 1997
- 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
Other 510(k)s with product code DDQ
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Questions and answers
When was N-Assay Tia Antithrombin III Test Kit cleared by the FDA?
N-Assay Tia Antithrombin III Test Kit (K972257) received a 510(k) decision of Substantially Equivalent on October 20, 1997, 125 days after the submission was received.
What is the product code of K972257?
The FDA product code is DDQ – Antigen, Antiserum, Control, Antithrombin Iii, a Class II (moderate risk) device regulated under 21 CFR 864.7060.