510(k) K842662
- Device
- ANTI-EPSTEIN-BARR VIRUS KIT
- Applicant
- AMICO LAB, INC.
- 510(k) number
- K842662
- Product code
- GNP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-12-12
- Date received
- 1984-07-10
- Regulation
- 866.3235
- Classification name
- Antiserum, Cf, Epstein-barr Virus
- Medical specialty
- Microbiology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- TN US 37209 37209
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 |
| K871373 | EBV-CHECK(TM) TEST KIT (IGG) | Diagnostic Technology, Inc. | 1987-06-25 |
| 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 |
Legacy Summary#
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FDA Review#
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