Epstein-Barr Virus Combi Test, Ebv Combi Test
FDA 510(k) K933251 · Virion (U.S.), Inc.
510(k) numberK933251
Submission
- Device name
- Epstein-Barr Virus Combi Test, Ebv Combi Test
- Applicant
- Virion (U.S.), Inc.
Morristown, NJ, US - Received
- July 2, 1993
- Decision date
- June 13, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K910872 | Ebv Igg Elisa TestMCD · Traditional | Gull Laboratories, Inc. | 04/12/1991SE |
More from Gull Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921618 | Coxsackie Virus B1-B6 CF AntigensGNG · Traditional | 06/29/1992SE |
| K905306 | Mumps Complement-Fixation (C.F.) AntigenGRC · Traditional | 06/17/1991SE |
| K905385 | P.I.V. Complement-Fixation (C.F.) AntigenGQS · Traditional | 03/21/1991SE |
| K864981 | Toxoplasma GondiiGMN · Traditional | 10/30/1987SE |
Questions and answers
When was Epstein-Barr Virus Combi Test, Ebv Combi Test cleared by the FDA?
Epstein-Barr Virus Combi Test, Ebv Combi Test (K933251) received a 510(k) decision of Substantially Equivalent on June 13, 1994, 346 days after the submission was received.
What is the product code of K933251?
The FDA product code is MCD – Antigen, Ebv, Capsid, a Class I (low risk) device regulated under 21 CFR 866.3235.