Aca Antithrombin III Plasminogen Calib
FDA 510(k) K812626 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK812626
Submission
- Device name
- Aca Antithrombin III Plasminogen Calib
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Mchenry, IL, US - Received
- September 15, 1981
- Decision date
- November 24, 1981
- 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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| 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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Questions and answers
When was Aca Antithrombin III Plasminogen Calib cleared by the FDA?
Aca Antithrombin III Plasminogen Calib (K812626) received a 510(k) decision of Substantially Equivalent on November 24, 1981, 70 days after the submission was received.
What is the product code of K812626?
The FDA product code is JBQ – Antithrombin Iii Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7060.