510(k) K901840
- Device
- (eia) For Igm Antibody To Ebv Vca In Human Serum
- Applicant
- GRANBIO, INC.
- 510(k) number
- K901840
- Product code
- LJN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-09-12
- Date received
- 1990-04-24
- 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
- J GRANLUND,PHD
- Address
- P.O. Box 892140 Temecula CA US 92589 92589
FDA Registration Numbers#
- 3032705
- 1641328
- 2915274
- 2029372
- 1419968
- 2918768
- 2242436
- 3004973408
Source Documents#
510(k) summary PDF not indicated by FDA
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| 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 |
| K896594 | EBV VCA ANTIBODY (IGM) | Hillcrest Biologicals | 1990-01-16 |
| K893240 | BION EBV-M (VCA) TEST SYSTEM | Bion Ent., Ltd. | 1989-07-14 |