Ebv Igg Elisa Test
FDA 510(k) K910872 · Gull Laboratories, Inc.
510(k) numberK910872
Submission
- Device name
- Ebv Igg Elisa Test
- Applicant
- Gull Laboratories, Inc.
Salt Lake City, UT, US - Received
- March 1, 1991
- Decision date
- April 12, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MCD – Antigen, Ebv, Capsid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3235
- Specialty
- Microbiology
Other 510(k)s with product code MCD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K984126 | The Aptus (Automated) Application of the Ebv-Vca Igg Elisa Test System. an Enzyme Linked…MCD · Traditional | Zeus Scientific, Inc. | 01/11/1999SE |
| K933251 | Epstein-Barr Virus Combi Test, Ebv Combi TestMCD · Traditional | Virion (U.S.), Inc. | 06/13/1994SE |
| K925689 | Meridian Ebv-Igg Test KitMCD · Traditional | Fuller Laboratories, Inc. | 10/12/1993SE |
| K924091 | Ebv-Vca Igg Elisa Test SystemMCD · Traditional | Zeus Scientific, Inc. | 01/11/1993SE |
| K920412 | Modified Ortho Ebv Vca-Igg ElisaMCD · Traditional | Ortho Diagnostic Systems, Inc. | 06/22/1992SE |
| K911571 | Epstein-Barr Virus Vca-Igg Antibody Elisa TestMCD · Traditional | Ortho Diagnostic Systems, Inc. | 06/10/1991SE |
| K911570 | Epstein-Barr Virus Vca-Igm Antibody Elisa TestMCD · Traditional | Ortho Diagnostic Systems, Inc. | 06/10/1991SE |
More from Ortho Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983541 | HSV 1+2 Igg Elisa TestLGC · Traditional | 02/26/1999SE |
| K971857 | Mumps Igg Elisa TestyLJY · Traditional | 11/04/1997SE |
| K962343 | Toxo Igg Elisa TestLGD · Traditional | 03/24/1997SE |
| K935730 | Ebna Igg Elisa TestLLM · Traditional | 09/19/1995SE |
| K940093 | Ebv-Ea(D) Igg Elisa TestLSE · Traditional | 09/15/1995SE |
| K941046 | VZV Igg Elisa TestLFY · Traditional | 08/24/1995SE |
| K941198 | Ebv LGG Elisa TestLSE · Traditional | 08/23/1995SE |
| K932333 | Protectoral Ultrasonic Handpiece ProcessorEFB · Traditional | 08/15/1995SE |
| K941624 | Rubella Igg Elisa TestLFX · Traditional | 08/04/1995SE |
| K922759 | HSV-2 Igm Elisa Test--ModificationLGC · Traditional | 10/05/1992SE |
Questions and answers
When was Ebv Igg Elisa Test cleared by the FDA?
Ebv Igg Elisa Test (K910872) received a 510(k) decision of Substantially Equivalent on April 12, 1991, 42 days after the submission was received.
What is the product code of K910872?
The FDA product code is MCD – Antigen, Ebv, Capsid, a Class I (low risk) device regulated under 21 CFR 866.3235.