Turbox Antithrombin III
FDA 510(k) K884144 · Unipath , Ltd.
510(k) numberK884144
Submission
- Device name
- Turbox Antithrombin III
- Applicant
- Unipath , Ltd.
Bedford Mk41 Oqg, GB - Received
- September 30, 1988
- Decision date
- December 20, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K022195 | Coamatic AT-400JBQ · Traditional | Instrumentation Laboratory CO | 08/07/2002SE |
| K994238 | Il Test Liquid AntithrombinJBQ · Traditional | Instrumentation Laboratory CO | 06/23/2000SE |
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Questions and answers
When was Turbox Antithrombin III cleared by the FDA?
Turbox Antithrombin III (K884144) received a 510(k) decision of Substantially Equivalent on December 20, 1988, 81 days after the submission was received.
What is the product code of K884144?
The FDA product code is JBQ – Antithrombin Iii Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7060.