Aft System Proficiency Testing Program
FDA 510(k) K820088 · Calbiochem-Behring Corp.
510(k) numberK820088
Submission
- Device name
- Aft System Proficiency Testing Program
- Applicant
- Calbiochem-Behring Corp.
Mchenry, IL, US - Received
- January 13, 1982
- Decision date
- January 26, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
Other 510(k)s with product code DBL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K180202 | Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno ConceptsDBL · Traditional | Immuno Concepts, N.A. , Ltd. | 10/19/2018SE |
| K980312 | Nova Lite EndomysialDBL · Traditional | Inova Diagnostics, Inc. | 04/02/1998SE |
| K974169 | Wielisa Anti-Gbm Test SystemDBL · Traditional | Wieslab AB | 02/17/1998SE |
| K971464 | Immunoscan Anti-Gbm Quantitative KitDBL · Traditional | Euro-Diagnostica AB | 10/29/1997SE |
| K971658 | Mouse Liver Kidney Stomach Diagnostic Test KitDBL · Traditional | Jay H. Geller | 05/23/1997SE |
| K963525 | Diastat Anti-Glomerular Basement Membrane KitDBL · Traditional | Shield Diagnostics, Ltd. | 11/07/1996SE |
| K955431 | Rit Liver, Kidney, Stomach Ifa KitDBL · Traditional | The Binding Site, Ltd. | 04/23/1996SE |
| K953495 | Eia Kit for the Detection of GBM AntibodiesDBL · Traditional | Scimedx Corp. | 04/10/1996SE |
| K944192 | Anti-Nuclear Antibody (Ana) Test Kit W/Rat LiverDBL · Traditional | Light Diagnostics | 03/06/1995SE |
| K944191 | Anti-Nuclear Antibody(Ana) Test Kit W/Mouse LiverDBL · Traditional | Light Diagnostics | 03/06/1995SE |
More from Light Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K831811 | Revolution Radial Immunodiffusion PlateJZQ · Traditional | 07/28/1983SE |
| K831036 | Ena Test Kit SM & RNP Auto AntibodyLLL · Traditional | 04/27/1983SE |
| K830214 | Aft System IIIDHN · Traditional | 03/09/1983SE |
| K820812 | Creatine Kinase-Mb KitJHY · Traditional | 04/12/1982SE |
| K813493 | Enzygnost TM Rubella IgmLFX · Traditional | 03/04/1982SE |
| K812458 | PadacJTO · Traditional | 09/23/1981SE |
| K810718 | C-Peptice ReagentsJKD · Traditional | 03/31/1981SE |
| K810669 | Pantrak E.K.CIW · Traditional | 03/31/1981SE |
| K810404 | Rheumatoid Factors Reference SerumDHR · Traditional | 03/11/1981SE |
| K810309 | Rubella Antibodies Test ReagentsGOL · Traditional | 03/11/1981SE |
Questions and answers
When was Aft System Proficiency Testing Program cleared by the FDA?
Aft System Proficiency Testing Program (K820088) received a 510(k) decision of Substantially Equivalent on January 26, 1982, 13 days after the submission was received.
What is the product code of K820088?
The FDA product code is DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5660.