Beckman Antithrombin III Reagent Kit
FDA 510(k) K901977 · Beckman Instruments, Inc.
510(k) numberK901977
Submission
- Device name
- Beckman Antithrombin III Reagent Kit
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- May 2, 1990
- Decision date
- August 6, 1990
- 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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|---|---|---|---|
| K242952 | INNOVANCE AntithrombinJBQ · Traditional | Siemens Healthcare Diagnostic Products GmbH | 03/28/2025SE |
| K081769 | Innovance Antithrombin with Models OPFH03, OPFHO5JBQ · Traditional | Siemens Healthcare Diagnostics | 05/28/2009SE |
| K070301 | Hemosil AntithrombinJBQ · Special | Instrumentation Laboratory CO | 02/23/2007SE |
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| K043007 | Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5, Reference # 221105JBQ · Traditional | Hyphen Biomed | 11/07/2005SE |
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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 Beckman Antithrombin III Reagent Kit cleared by the FDA?
Beckman Antithrombin III Reagent Kit (K901977) received a 510(k) decision of Substantially Equivalent on August 6, 1990, 96 days after the submission was received.
What is the product code of K901977?
The FDA product code is JBQ – Antithrombin Iii Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7060.