510(k) K935809
- Device
- CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY
- Applicant
- LIGHT DIAGNOSTICS
- 510(k) number
- K935809
- Product code
- GQH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-05-05
- Date received
- 1993-12-02
- Regulation
- 866.3175
- Classification name
- Antigen, Cf (including Cf Control), Cytomegalovirus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DALE DEMBRO
- Address
- 28835 Single Oak Dr. Temecula CA US 92590 92590
FDA Registration Numbers#
- 2242436
- 2029372
- 1419968
- 3004973408
- 1181055
Source Documents#
Other 510(k) Records For Product Code GQH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K982311 | BARTELS CINAKIT CMV ANTIGENEMIA | Intracel Corp. | 1998-12-14 |
| K964875 | CMV ANTIGEN CONTROL SLIDES | Viral Antigens, Inc. | 1997-03-18 |
| K882835 | INDIRECT FLUORESCENT ASSAY FOR (HCMV) | Stellar Bio Systems, Inc. | 1988-12-05 |
| K882024 | FITC MURINE MONOCLONAL ANTI-CMV IGG | Whittaker Bioproducts, Inc. | 1988-08-03 |
| K881932 | ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT | Ortho Diagnostic Systems, Inc. | 1988-08-01 |
| K880679 | BION CMV-G TEST SYSTEM | Bion Ent., Ltd. | 1988-06-03 |
| K880290 | MICROTRAK CMV CULTURE CONFIRMATION TEST | Syva Co. | 1988-04-19 |
| K872576 | COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION | Enzo Biochem, Inc. | 1987-12-04 |
| K873114 | CYTOMEGALOVIRUS CONTROL SLIDES | Medical Diagnostic Technologies, Inc. | 1987-09-25 |
| K864565 | MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT | Serono Diagnostics, Inc. | 1987-02-19 |
| K843657 | CYTOMEGALOVIRUS | Institute Virion , Ltd. | 1985-09-26 |
| K833089 | CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II | Clinical Sciences, Inc. | 1984-05-02 |
| K811671 | CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM | Zeus Scientific, Inc. | 1981-09-16 |
| K802930 | CYTOMEGALO VIRUS & CONTROLS | Orion Diagnostica, Inc. | 1981-01-09 |
| K801963 | CMV TEST KIT | Immuno-Diagnostic Products, Inc. | 1980-10-23 |
Legacy Summary#
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FDA Review#
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