510(k) K871373
- Device
- EBV-CHECK(TM) TEST KIT (IGG)
- Applicant
- DIAGNOSTIC TECHNOLOGY, INC.
- 510(k) number
- K871373
- Product code
- GNP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-06-25
- Date received
- 1987-04-07
- Regulation
- 866.3235
- Classification name
- Antiserum, Cf, Epstein-barr Virus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT E LIND
- Address
- 240 Vanderbilt Motor Pkwy. Hauppauge NY US 11788 11788
FDA Registration Numbers#
- 1318354
- 2918768
- 1181055
- 3007208259
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GNP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K020707 | EBV-EBNA IGG ELISA KIT, MODEL EBG-100 | Pan Bio Pty. , Ltd. | 2002-06-13 |
| K020717 | EBV V VCA IGM ELISA KIT MODEL# EBM-200 | Pan Bio Pty. , Ltd. | 2002-06-13 |
| K020706 | EBV-VCA IGG ELISA TEST, MODEL EBG-100 | Pan Bio Pty. , Ltd. | 2002-06-13 |
| K981831 | IS EBV-EA-D IGG ELISA TEST SYSTEM | Diamedix Corp. | 1999-02-16 |
| K981829 | IS EBV-EBNA-1 IGG ELISA TEST SYSTEM | Diamedix Corp. | 1999-02-16 |
| K901156 | EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM | Granbio, Inc. | 1990-09-12 |
| K883670 | SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI | Electro-Nucleonics, Inc. | 1989-04-28 |
| K884591 | EBV-VCA ANTIBODY (IGG) | Hillcrest Biologicals | 1989-01-24 |
| K880883 | EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) | Immuno Concepts, Inc. | 1988-08-30 |
| K880885 | EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) | Immuno Concepts, Inc. | 1988-08-30 |
| K861121 | THE GOLDEN QUAD TEST (EBV) | Microbiological Research Corp. | 1987-02-02 |
| K864347 | INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA | Granbio, Inc. | 1987-02-02 |
| K863408 | EBV/VCA-CHECK(TM) ANTIGEN SLIDES | Diagnostic Technology, Inc. | 1986-11-28 |
| K854207 | EBV(EPSTEIN-BARR VIRUS) TEST KIT | Immuno-Diagnostic Products, Inc. | 1986-04-24 |
| K853484 | INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT | Biotech Research Laboratories, Inc. | 1986-02-05 |
Legacy Summary#
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FDA Review#
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