Avi-D Control

FDA 510(k) K811713 · Ortho Diagnostic Systems, Inc.

Substantially Equivalent

510(k) numberK811713

Submission

Device name
Avi-D Control
Applicant
Ortho Diagnostic Systems, Inc.
Carpinteria, CA, US
Received
June 17, 1981
Decision date
October 23, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KSF – Kit, Quality Control For Blood Banking Reagents
Device class
Class II (moderate risk)
Regulation
21 CFR 864.9650
Specialty
Hematology

Other 510(k)s with product code KSF

510(k)DeviceApplicantDecision
K810599Dade RH Control ReagentKSF · Traditional American Dade03/31/1981SE
K801425RH ControlKSF · Traditional North American Biologicals, Inc.07/14/1980SE
K800658Rst-Series ControlKSF · Traditional Gamma Biologicals, Inc.04/16/1980SE
K800310Ortho Antisera ControlKSF · Traditional Ortho Diagnostics, Inc.03/05/1980SE
K800239Rh-Hr Negative Control ReagentKSF · Traditional Gotham Biologics, Inc.02/21/1980SE
K790249Test CellsKSF · Traditional Hyland Therapeutic Div., Travenol Laboratories05/16/1979SE
K790025Counter Check, H001, H002, H003KSF · Traditional Diagnostic Technology, Inc.01/17/1979SE
K780665RecapKSF · Traditional Bca Biological Corp. of America06/06/1978SE
K780097Quality Control System, SpectraKSF · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic04/24/1978SE
K771814Reagent Confidence SeraKSF · Traditional Ortho Diagnostics, Inc.11/07/1977SE

More from Ortho Diagnostics, Inc.

510(k)DeviceDecision
K951459Ortho-Mune Okt 4A (CD4) - Monoclonal Antibody (Murine) Fitc ConjugateGKZ · Traditional 07/14/1997SE
K951632Ortho-Mune Ok-Combo Control IGG2A-FITC/IGG2A-PE Monoclonal Antibody (Murine)GKZ · Traditional 03/06/1997SE
K964754Ortho-Mune Okb (CD19)- Monoclonal Antibody (Murine) Phycoerythrine ConjugateGKZ · Traditional 01/22/1997SE
K963902Quantitative Fibrinogen AssayGIS · Traditional 11/29/1996SE
K951100Ortho-Mune Ok-Combo CD3-FITC/CD19-PE (OKT3/OKB19A Monolclonal Antibody (Murine)GKZ · Traditional 05/13/1996SE
K950625Ortho-Mune Ok-Combo CD40FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine)GKZ · Traditional 05/13/1996SE
K950568Ortho-Mune Ok-Combo CD3-FITC/CD4-PE (OKT2/OKT4A) Monoclonal Antibody (Murine)GKZ · Traditional 05/13/1996SE
K950482Ortho-Mune Ok-Comvo CD3-FITC/CD8-PE (Okt 3/OKT8) Monoclonal Antibody (Murine)GKZ · Traditional 05/10/1996SE
K935720Ortho Count Calibration Kit for Ortho Cytoronabsolute Laser Flow Cytometry SystemGKZ · Traditional 05/09/1996SE
K954570Ortho Immunocount Flow Cytometry SystemGKZ · Traditional 04/30/1996SE

Questions and answers

When was Avi-D Control cleared by the FDA?

Avi-D Control (K811713) received a 510(k) decision of Substantially Equivalent on October 23, 1981, 128 days after the submission was received.

What is the product code of K811713?

The FDA product code is KSF – Kit, Quality Control For Blood Banking Reagents, a Class II (moderate risk) device regulated under 21 CFR 864.9650.