IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530
FDA 510(k) clearance K872942 · decided 1988-01-11
Clearance details
- K-number
- K872942
- Device name
- IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530
- Applicant
- Clinical Sciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-27
- Decision date
- 1988-01-11
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- LKQ
- Device class
- 2
- Regulation number
- 866.3175
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Whippany, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Clinical Sciences
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| CMV IGM MICROASSAY (K871832) | Diamedix Corp. | 1987-08-07 |
| FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES (K863798) | Whittaker Bioproducts, Inc. | 1987-04-14 |
Recalls involving this device
No recalls on record reference this clearance.