Actichrome Atiii Kit
FDA 510(k) K893608 · American Diagnostic Corp.
510(k) numberK893608
Submission
- Device name
- Actichrome Atiii Kit
- Applicant
- American Diagnostic Corp.
New York, NY, US - Received
- May 10, 1989
- Decision date
- June 23, 1989
- 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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| K070301 | Hemosil AntithrombinJBQ · Special | Instrumentation Laboratory CO | 02/23/2007SE |
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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 Actichrome Atiii Kit cleared by the FDA?
Actichrome Atiii Kit (K893608) received a 510(k) decision of Substantially Equivalent on June 23, 1989, 44 days after the submission was received.
What is the product code of K893608?
The FDA product code is JBQ – Antithrombin Iii Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7060.