510(k) K971857
- Device
- MUMPS IGG ELISA TESTY
- Applicant
- GULL LABORATORIES, INC.
- 510(k) number
- K971857
- Product code
- LJY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-11-04
- Date received
- 1997-05-20
- Regulation
- 866.3380
- Classification name
- Enzyme Linked Immunoabsorbent Assay, Mumps Virus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- FRED W RACHFORD
- Address
- 1011 Murray Holladay Rd. Salt Lake City UT US 84117 84117
FDA Registration Numbers#
- 2242436
- 3032705
- 3002800697
- 9610240
- 3007361513
- 8020790
- 9615056
- 3007208259
- 2029372
- 2245285
- 2090110
- 1318354
- 2915274
- 3005542422
- 3003268355
- 3008191245
- 2133982
- 1641328
- 3007118747
Source Documents#
Other 510(k) Records For Product Code LJY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K991274 | MUMPS IGG ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1999-09-03 |
| K980059 | SERAQUEST MUMPS IGG | Quest Intl., Inc. | 1998-04-23 |
| K961204 | MUMPS IGG TEST | Zeus Scientific, Inc. | 1996-07-18 |
| K925209 | MUMPS STAT | Biowhittaker Molecular Applications, Inc. | 1994-10-14 |
| K923903 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA | Biomerieux Vitek, Inc. | 1993-08-09 |
| K897006 | PHARMACIA MUMPS IGG ELISA | Pharmacia Eni Diagnostics, Inc. | 1990-07-26 |
| K830045 | MUMPSELISA TEST KIT | M.A. Bioproducts | 1983-05-13 |
Legacy Summary#
summary
FDA Review#
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