Anti-Endomysial Antibody Test
FDA 510(k) K912551 · Immco Diagnostics, Inc.
510(k) numberK912551
Submission
- Device name
- Anti-Endomysial Antibody Test
- Applicant
- Immco Diagnostics, Inc.
Buffalo, NY, US - Received
- June 11, 1991
- Decision date
- June 9, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
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| 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 |
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| 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 |
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Questions and answers
When was Anti-Endomysial Antibody Test cleared by the FDA?
Anti-Endomysial Antibody Test (K912551) received a 510(k) decision of Substantially Equivalent on June 9, 1993, 729 days after the submission was received.
What is the product code of K912551?
The FDA product code is DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5660.