Koagulab 40-A Automated Coagulation Sys
FDA 510(k) K823131 · Ortho Diagnostic Systems, Inc.
510(k) numberK823131
Submission
- Device name
- Koagulab 40-A Automated Coagulation Sys
- Applicant
- Ortho Diagnostic Systems, Inc.
Carpinteria, CA, US - Received
- October 25, 1982
- Decision date
- December 9, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQG – Instrument, Coagulation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5400
- Specialty
- Hematology
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| K852492 | CoagulatorKQG · Traditional | Med USA | 08/13/1985SE |
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| K964754 | Ortho-Mune Okb (CD19)- Monoclonal Antibody (Murine) Phycoerythrine ConjugateGKZ · Traditional | 01/22/1997SE |
| K963902 | Quantitative Fibrinogen AssayGIS · Traditional | 11/29/1996SE |
| K951100 | Ortho-Mune Ok-Combo CD3-FITC/CD19-PE (OKT3/OKB19A Monolclonal Antibody (Murine)GKZ · Traditional | 05/13/1996SE |
| K950625 | Ortho-Mune Ok-Combo CD40FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine)GKZ · Traditional | 05/13/1996SE |
| K950568 | Ortho-Mune Ok-Combo CD3-FITC/CD4-PE (OKT2/OKT4A) Monoclonal Antibody (Murine)GKZ · Traditional | 05/13/1996SE |
| K950482 | Ortho-Mune Ok-Comvo CD3-FITC/CD8-PE (Okt 3/OKT8) Monoclonal Antibody (Murine)GKZ · Traditional | 05/10/1996SE |
| K935720 | Ortho Count Calibration Kit for Ortho Cytoronabsolute Laser Flow Cytometry SystemGKZ · Traditional | 05/09/1996SE |
| K954570 | Ortho Immunocount Flow Cytometry SystemGKZ · Traditional | 04/30/1996SE |
Questions and answers
When was Koagulab 40-A Automated Coagulation Sys cleared by the FDA?
Koagulab 40-A Automated Coagulation Sys (K823131) received a 510(k) decision of Substantially Equivalent on December 9, 1982, 45 days after the submission was received.
What is the product code of K823131?
The FDA product code is KQG – Instrument, Coagulation, a Class II (moderate risk) device regulated under 21 CFR 864.5400.