Antithrombin III Immunological NL Test Kit
FDA 510(k) K913667 · The Binding Site, Ltd.
510(k) numberK913667
Submission
- Device name
- Antithrombin III Immunological NL Test Kit
- Applicant
- The Binding Site, Ltd.
Los Angeles, CA, US - Received
- August 19, 1991
- Decision date
- January 3, 1992
- 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 Antithrombin III Immunological NL Test Kit cleared by the FDA?
Antithrombin III Immunological NL Test Kit (K913667) received a 510(k) decision of Substantially Equivalent on January 3, 1992, 137 days after the submission was received.
What is the product code of K913667?
The FDA product code is JBQ – Antithrombin Iii Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7060.