ENZYGNOST ANTI-CMV IGG TEST
FDA 510(k) clearance K863488 · decided 1987-07-20
Clearance details
- K-number
- K863488
- Device name
- ENZYGNOST ANTI-CMV IGG TEST
- Applicant
- Behring Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-09-09
- Decision date
- 1987-07-20
- Days to decision
- 314 days
- Clearance type
- Traditional
- Product code
- GQI
- Device class
- 2
- Regulation number
- 866.3175
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- La Jolla, CA, 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 |
|---|---|---|
| ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS (K952254) | Pyramid Biological Corp. | 1995-11-16 |
| CMV IGG HUMAN SERUM CONTROLS (K951800) | Pyramid Biological Corp. | 1995-11-16 |
| CMV EARLY ANTIGEN TEST (K942171) | Neogenex | 1994-06-30 |
| VIRGO (R) CMV-IGG ELISA (K883102) | Electro-Nucleonics, Inc. | 1989-02-08 |
| DETECTADOT SYSTEM 2000 CMV IGG TEST (K875159) | Gull Laboratories, Inc. | 1988-05-06 |
| CMV MICROASSAY (K864420) | Diamedix Corp. | 1987-02-02 |
| THE GOLDEN QUAD TEST (CMV) (K861123) | Microbiological Research Corp. | 1987-02-02 |
| CYTOMEGALOVIRUS IGG EIA TEST KIT (K862705) | Labsystems, Inc. | 1986-10-01 |
| COR DOT CMV (K853989) | Cordis Corp. | 1986-06-13 |
| CYTOTECH CMV IGG EIA (K860493) | Cytotech, Inc. | 1986-05-20 |
| CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530 (K854666) | Clinical Sciences, Inc. | 1986-02-05 |
| CYTOMEGALOVIRUS IGG EIA TEST KIT (K843189) | Labsystems, Inc. | 1986-01-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OPUS(R) CEA TEST SYSTEM (P920021/S001) | Behring Diagnostics, Inc. | 1996-02-23 |