510(k) K864565
- Device
- MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT
- Applicant
- SERONO DIAGNOSTICS, INC.
- 510(k) number
- K864565
- Product code
- GQH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-02-19
- Date received
- 1986-11-19
- Regulation
- 866.3175
- Classification name
- Antigen, Cf (including Cf Control), Cytomegalovirus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PHILIP M FANTASIA
- Address
- 100 Longwater Cir. Norwell MA US 02061 02061
FDA Registration Numbers#
- 2029372
- 1419968
- 2242436
- 1181055
- 3004973408
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K935809 | CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY | Light Diagnostics | 1994-05-05 |
| 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 |
| 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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