THE CMV-IGM TEST
FDA 510(k) clearance K860450 · decided 1986-05-13
Clearance details
- K-number
- K860450
- Device name
- THE CMV-IGM TEST
- Applicant
- Microbiological Research Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-04
- Decision date
- 1986-05-13
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- LKQ
- Device class
- 2
- Regulation number
- 866.3175
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Bountiful, UT, 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 |
|---|---|---|
| IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, (K100433) | Siemens Healthcare Diagnostics | 2010-05-13 |
| ACCURUN 146 CMV IGM POSITIVE CONTROL (K972884) | Boston Biomedica, Inc. | 1997-08-22 |
| VIDAS CMV IGM ASSAY (K933549) | Biomerieux Vitek, Inc. | 1994-08-02 |
| BARTELS CYTOMEGALOVIRUS IGM EIA (K922580) | Baxter Diagnostics, Inc. | 1993-04-08 |
| ELISA CMV IGM (K914789) | Sclavo, Inc. | 1992-03-04 |
| OPUS(R) ANTI CMV-M (K913080) | Pb Diagnostics, Inc. | 1991-10-28 |
| CMV-IGM IFA TEST SYSTEM (K900743) | Zeus Scientific, Inc. | 1990-04-26 |
| CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) (K893465) | Immuno Concepts, Inc. | 1989-07-25 |
| CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) (K893466) | Immuno Concepts, Inc. | 1989-07-14 |
| ABBOTT CMV-M EIA KIT (K872881) | Abbott Laboratories | 1988-05-13 |
| IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 (K872942) | Clinical Sciences, Inc. | 1988-01-11 |
| CMV IGM MICROASSAY (K871832) | Diamedix Corp. | 1987-08-07 |
Recalls involving this device
No recalls on record reference this clearance.