DIAMEDIX IS-MEASLES IGG TEST SYSTEM
FDA 510(k) clearance K974552 · decided 1998-01-28
Clearance details
- K-number
- K974552
- Device name
- DIAMEDIX IS-MEASLES IGG TEST SYSTEM
- Applicant
- Diamedix Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-04
- Decision date
- 1998-01-28
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- LJB
- Device class
- 1
- Regulation number
- 866.3520
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Miami, FL, 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 |
|---|---|---|
| QUANTA LITE RUBEOLA (MEASLES) IGG (K971620) | Inova Diagnostics, Inc. | 1997-07-22 |
| BARTELS RUBEOLA IGM EIA (K922335) | Baxter Diagnostics, Inc. | 1992-09-02 |
| BARTELS RUBEOLA IGG EIA (K922330) | Baxter Diagnostics, Inc. | 1992-09-02 |
| VIRATEST-DIA(TM) MEASLES (RUBEOLA) (K910290) | Virus Reference Laboratory, Inc. | 1992-03-18 |
| RUBEOLA IGM ELISA TEST (K904083) | Gull Laboratories, Inc. | 1991-01-03 |
| MEASLES IGG MICROASSAY (K903961) | Diamedix Corp. | 1990-12-28 |
| RUBEOLA IGG ELISA TEST (K904854) | Gull Laboratories, Inc. | 1990-12-04 |
| RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 (K891990) | Clinical Sciences, Inc. | 1989-06-15 |
| VIRGO(TM) MEASLES IGG ELISA (K873925) | Electro-Nucleonics Laboratories, Inc. | 1988-02-24 |
| MEASELISA TEST KIT (K821762) | M.A. Bioproducts | 1982-07-30 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quan recall (Z-0607-2009) | Diamedix Corporation | 2009-01-07 |