Biopool Protein C Eid Kit and Bulk Plates
FDA 510(k) K902566 · Biopool AB
510(k) numberK902566
Submission
- Device name
- Biopool Protein C Eid Kit and Bulk Plates
- Applicant
- Biopool AB
Ontario, L7l 6b8, CA - Received
- June 11, 1990
- Decision date
- August 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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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 Biopool Protein C Eid Kit and Bulk Plates cleared by the FDA?
Biopool Protein C Eid Kit and Bulk Plates (K902566) received a 510(k) decision of Substantially Equivalent on August 9, 1990, 59 days after the submission was received.
What is the product code of K902566?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.