Spectrolyse Atiii Kit
FDA 510(k) K902530 · Biopool AB
510(k) numberK902530
Submission
- Device name
- Spectrolyse Atiii Kit
- Applicant
- Biopool AB
Ontario, L7l 6b8, CA - Received
- June 5, 1990
- Decision date
- August 9, 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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| K070301 | Hemosil AntithrombinJBQ · Special | Instrumentation Laboratory CO | 02/23/2007SE |
| K062431 | Hemosil Liquid AntithrombinJBQ · Special | Instrumentation Laboratory CO | 09/01/2006SE |
| K043007 | Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5, Reference # 221105JBQ · Traditional | Hyphen Biomed | 11/07/2005SE |
| K033775 | Hemosil Liquid Antithrombin XLJBQ · Special | Instrumentation Laboratory CO | 01/02/2004SE |
| 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 |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K941752 | Spectrolyse Antiplasmin KitGGP · Traditional | 09/25/1995SESK |
| K942087 | Biopool VWF Eld Kit and VWF Eld Bulk PlatesGGP · Traditional | 07/13/1995SE |
| K934314 | Tintelizer(R) TpaGGP · Traditional | 02/23/1994SE |
| K923499 | Spectrolyse Heparin KitKFF · Traditional | 01/27/1994SE |
| K932463 | Bioclot laGIR · Traditional | 09/27/1993SE |
| K920668 | Minutex D-Dimer Latex TestGHH · Traditional | 10/16/1992SE |
| K922782 | Spectrolyse/Pl Pai KitGGP · Traditional | 10/09/1992SE |
| K915163 | Protein S Eid Kit and Protein S Eid Bulk PlatesGGP · Traditional | 01/06/1992SE |
| K914307 | Spectrolyse Protein C KitGGP · Traditional | 12/09/1991SE |
| K912025 | Spectrolyse Plasminogen SK KitGGP · Traditional | 08/22/1991SE |
Questions and answers
When was Spectrolyse Atiii Kit cleared by the FDA?
Spectrolyse Atiii Kit (K902530) received a 510(k) decision of Substantially Equivalent on August 9, 1990, 65 days after the submission was received.
What is the product code of K902530?
The FDA product code is JBQ – Antithrombin Iii Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7060.