CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM
FDA 510(k) clearance K811671 · decided 1981-09-16
Clearance details
- K-number
- K811671
- Device name
- CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM
- Applicant
- Zeus Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-06-15
- Decision date
- 1981-09-16
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- GQH
- Device class
- 2
- Regulation number
- 866.3175
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BARTELS CINAKIT CMV ANTIGENEMIA (K982311) | Intracel Corp. | 1998-12-14 |
| CMV ANTIGEN CONTROL SLIDES (K964875) | Viral Antigens, Inc. | 1997-03-18 |
| CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY (K935809) | Light Diagnostics | 1994-05-05 |
| INDIRECT FLUORESCENT ASSAY FOR (HCMV) (K882835) | Stellar Bio Systems, Inc. | 1988-12-05 |
| FITC MURINE MONOCLONAL ANTI-CMV IGG (K882024) | Whittaker Bioproducts, Inc. | 1988-08-03 |
| ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT (K881932) | Ortho Diagnostic Systems, Inc. | 1988-08-01 |
| BION CMV-G TEST SYSTEM (K880679) | Bion Ent., Ltd. | 1988-06-03 |
| MICROTRAK CMV CULTURE CONFIRMATION TEST (K880290) | Syva Co. | 1988-04-19 |
| COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION (K872576) | Enzo Biochem, Inc. | 1987-12-04 |
| CYTOMEGALOVIRUS CONTROL SLIDES (K873114) | Medical Diagnostic Technologies, Inc. | 1987-09-25 |
| MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT (K864565) | Serono Diagnostics, Inc. | 1987-02-19 |
| CYTOMEGALOVIRUS (K843657) | Institute Virion , Ltd. | 1985-09-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM (P150042) | Zeus Scientific, Inc. | 2017-09-19 |
| ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM (P150045) | Zeus Scientific, Inc. | 2017-09-19 |
| FLUORO-CEP (R) PROGESTERONE (P900025/S001) | Zeus Scientific, Inc. | 1992-04-21 |
| FLUORO-CEP (R) PROGESTERONE (P900025/S002) | Zeus Scientific, Inc. | 1992-04-17 |
| FLUORO-CEP (R) PROGESTERONE (P900025) | Zeus Scientific, Inc. | 1990-09-26 |