Diacrom * Atiii
FDA 510(k) K832592 · Wellcome Diagnostics
510(k) numberK832592
Submission
- Device name
- Diacrom * Atiii
- Applicant
- Wellcome Diagnostics
Mchenry, IL, US - Received
- August 2, 1983
- Decision date
- September 29, 1983
- 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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| K023991 | Chromocheck Antithrombin 25; Chromocheck Antithrombin 50JBQ · Traditional | Precision Biologic | 04/28/2003SE |
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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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| K861634 | The Wellcome Rotavirus Latex Test ZL40LIQ · Traditional | 10/29/1986SE |
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Questions and answers
When was Diacrom * Atiii cleared by the FDA?
Diacrom * Atiii (K832592) received a 510(k) decision of Substantially Equivalent on September 29, 1983, 58 days after the submission was received.
What is the product code of K832592?
The FDA product code is JBQ – Antithrombin Iii Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7060.