Accucolor(Tm) Antithrombin III Chromogenic Assay
FDA 510(k) K935308 · Sigma Diagnostics, Inc.
510(k) numberK935308
Submission
- Device name
- Accucolor(Tm) Antithrombin III Chromogenic Assay
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- November 2, 1993
- Decision date
- May 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JBQ – Antithrombin Iii Quantitation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7060
- Specialty
- Hematology
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Questions and answers
When was Accucolor(Tm) Antithrombin III Chromogenic Assay cleared by the FDA?
Accucolor(Tm) Antithrombin III Chromogenic Assay (K935308) received a 510(k) decision of Substantially Equivalent on May 17, 1994, 196 days after the submission was received.
What is the product code of K935308?
The FDA product code is JBQ – Antithrombin Iii Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7060.