MUMPS IGG ELISA TEST SYSTEM
FDA 510(k) clearance K991274 · decided 1999-09-03
Clearance details
- K-number
- K991274
- Device name
- MUMPS IGG ELISA TEST SYSTEM
- Applicant
- Columbia Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-04-13
- Decision date
- 1999-09-03
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- LJY
- Device class
- 1
- Regulation number
- 866.3380
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Columbia, MD, 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 |
|---|---|---|
| SERAQUEST MUMPS IGG (K980059) | Quest Intl., Inc. | 1998-04-23 |
| MUMPS IGG ELISA TESTY (K971857) | Gull Laboratories, Inc. | 1997-11-04 |
| MUMPS IGG TEST (K961204) | Zeus Scientific, Inc. | 1996-07-18 |
| MUMPS STAT (K925209) | Biowhittaker Molecular Applications, Inc. | 1994-10-14 |
| VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA (K923903) | Biomerieux Vitek, Inc. | 1993-08-09 |
| PHARMACIA MUMPS IGG ELISA (K897006) | Pharmacia Eni Diagnostics, Inc. | 1990-07-26 |
| MUMPSELISA TEST KIT (K830045) | M.A. Bioproducts | 1983-05-13 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. tha recall (Z-0557-06) | Diasorin Inc. | 2006-02-23 |