510(k) K822734
- Device
- EBV IGM TEST
- Applicant
- GULL LABORATORIES, INC.
- 510(k) number
- K822734
- Product code
- JRY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-12-09
- Date received
- 1982-09-09
- Regulation
- 866.3235
- Classification name
- Antiserum, Fluorescent, Epstein-barr Virus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 2029372
- 1419968
- 3004973408
- 2242436
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JRY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K042118 | ATHENA MULTI-LYTE EBV IGG TEST SYSTEM | Zeus Scientific, Inc. | 2005-04-29 |
| K900974 | INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. | Stellar Bio Systems, Inc. | 1990-04-16 |
| K891785 | BION EBV-G (VCA) TEST SYSTEM | Bion Ent., Ltd. | 1989-08-31 |
| K884829 | EBV EARLY ANTIGEN (R+D) | Hillcrest Biologicals | 1989-04-12 |
| K822985 | EBV-M KIT | Litton Bionetics | 1982-12-03 |
| K821849 | EBV-VCA ANTIBODY ASSAY KIT | Biotech Research Laboratories, Inc. | 1982-08-12 |
| K811262 | EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI | Zeus Scientific, Inc. | 1981-05-27 |
| K780925 | EB-VCA, TEST, ANTIBODY, FLUORESCENT | Litton Bionetics | 1978-06-22 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases