510(k) K890639
- Device
- RESUBMITTED EBV/IGM-CHECK TEST KIT
- Applicant
- DIAGNOSTIC TECHNOLOGY, INC.
- 510(k) number
- K890639
- Product code
- LJN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-06-20
- Date received
- 1989-02-08
- Regulation
- 866.3235
- Classification name
- Antibody Igm, If, 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#
- 2918768
- 2242436
- 2029372
- 1419968
- 3004973408
- 1641328
- 3032705
- 2915274
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LJN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123021 | BIOPLEX 2200 EBV IGM KIT | Bio-Rad Laboratories | 2012-11-02 |
| K073381 | PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M | Focus Diagnostics, Inc. | 2008-08-04 |
| K042092 | ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM | Zeus Scientific, Inc. | 2005-04-12 |
| K033780 | MODIFICATION TO SERAQUEST VCA IGM | Quest Intl., Inc. | 2004-01-15 |
| K990977 | SERAQUEST EB VAC IGM | Quest Intl., Inc. | 1999-10-06 |
| K991459 | COPALIS EBV-M ANTIBODY ASSAY | DiaSorin, Inc. | 1999-05-14 |
| K973939 | IMMUNOWELL VCA IGM TEST | Genbio | 1998-08-10 |
| K931520 | EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY | Mrl Diagnostics | 1994-04-26 |
| K930020 | ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA | Ortho Diagnostic Systems, Inc. | 1993-07-16 |
| K922331 | BARTELS EPSTEIN-BARR VIRUS IGM EIA | Baxter Diagnostics, Inc. | 1992-09-02 |
| K915348 | EBV-VCA IGM ELISA | Pharmacia Diagnostics, Inc. | 1992-02-14 |
| K911362 | AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST | Amico Laboratories, Inc. | 1991-10-07 |
| K910042 | EBV IGM ELISA TEST | Gull Laboratories, Inc. | 1991-02-21 |
| K901840 | (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM | Granbio, Inc. | 1990-09-12 |
| K896594 | EBV VCA ANTIBODY (IGM) | Hillcrest Biologicals | 1990-01-16 |
Legacy Summary#
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FDA Review#
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