CMV-EA MAB TEST
FDA 510(k) clearance K912592 · decided 1991-12-04
Clearance details
- K-number
- K912592
- Device name
- CMV-EA MAB TEST
- Applicant
- Gull Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-10
- Decision date
- 1991-12-04
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- LIN
- Device class
- 2
- Regulation number
- 866.3175
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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| CMV BRITE ANTIGENEMIA TEST KIT (K951550) | Biotest Diagnostics Corp. | 1996-01-30 |
| PATHODX CYTOMEGALOVIRUS (K934798) | Diagnostic Products Corp. | 1994-03-25 |
| CMV-VUE(TM) CMV ANTIGEN DETECTION KIT (K921616) | Incstar Corp. | 1992-08-11 |
| OPUS CMV TEST SYSTEM (K905257) | Pb Diagnostic Systems, Inc. | 1991-04-17 |
| BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN (K904036) | Baxter Healthcare Corp | 1990-10-16 |
| CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY (K894002) | Baxter Healthcare Corp | 1989-08-10 |
| CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST) (K893468) | Immuno Concepts, Inc. | 1989-07-14 |
| CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST) (K893467) | Immuno Concepts, Inc. | 1989-07-14 |
Recalls involving this device
No recalls on record reference this clearance.