At-Iii Calibrator
FDA 510(k) K944279 · American Bioproducts Co.
510(k) numberK944279
Submission
- Device name
- At-Iii Calibrator
- Applicant
- American Bioproducts Co.
Parisppany, NJ, US - Received
- August 30, 1994
- Decision date
- April 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K023991 | Chromocheck Antithrombin 25; Chromocheck Antithrombin 50JBQ · Traditional | Precision Biologic | 04/28/2003SE |
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| K994238 | Il Test Liquid AntithrombinJBQ · Traditional | Instrumentation Laboratory CO | 06/23/2000SE |
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| K964716 | Sta Liatest Control [N]+[P] KitGGN · Traditional | 06/26/1997SE |
| K964718 | Sta D-Di Calibrator KitDAP · Traditional | 05/23/1997SE |
| K962675 | Sta - Liatest VWF Test KitGJT · Traditional | 10/25/1996SE |
| K962671 | Sta-Vwf Calibrator KitGJT · Traditional | 09/13/1996SE |
| K962674 | Sta - VWF Control [N]+[P] KitGGN · Traditional | 07/23/1996SE |
| K961579 | Sta Compact Automated Multi-Parametric AnalyzerGKP · Traditional | 07/10/1996SE |
| K955040 | At-Iii Control Plasma KitGGC · Traditional | 01/31/1996SE |
Questions and answers
When was At-Iii Calibrator cleared by the FDA?
At-Iii Calibrator (K944279) received a 510(k) decision of Substantially Equivalent on April 7, 1995, 220 days after the submission was received.
What is the product code of K944279?
The FDA product code is JBQ – Antithrombin Iii Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7060.