510(k) K873925
- Device
- VIRGO(TM) MEASLES IGG ELISA
- Applicant
- ELECTRO-NUCLEONICS LABORATORIES, INC.
- 510(k) number
- K873925
- Product code
- LJB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-02-24
- Date received
- 1987-09-25
- Regulation
- 866.3520
- Classification name
- Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LABREC, PH.D.
- Address
- 7101 Riverwood Dr. Columbia MD US 21046 21046
FDA Registration Numbers#
- 3007208259
- 3005542422
- 3032705
- 3007118747
- 2133982
- 8020790
- 3003268355
- 9610240
- 1641328
- 2242436
- 1318354
- 2090110
- 3008191245
- 2915274
- 2245285
- 9615056
- 3007361513
- 3002800697
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LJB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974552 | DIAMEDIX IS-MEASLES IGG TEST SYSTEM | Diamedix Corp. | 1998-01-28 |
| K971620 | QUANTA LITE RUBEOLA (MEASLES) IGG | Inova Diagnostics, Inc. | 1997-07-22 |
| K922330 | BARTELS RUBEOLA IGG EIA | Baxter Diagnostics, Inc. | 1992-09-02 |
| K922335 | BARTELS RUBEOLA IGM EIA | Baxter Diagnostics, Inc. | 1992-09-02 |
| K910290 | VIRATEST-DIA(TM) MEASLES (RUBEOLA) | Virus Reference Laboratory, Inc. | 1992-03-18 |
| K904083 | RUBEOLA IGM ELISA TEST | Gull Laboratories, Inc. | 1991-01-03 |
| K903961 | MEASLES IGG MICROASSAY | Diamedix Corp. | 1990-12-28 |
| K904854 | RUBEOLA IGG ELISA TEST | Gull Laboratories, Inc. | 1990-12-04 |
| K891990 | RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 | Clinical Sciences, Inc. | 1989-06-15 |
| K821762 | MEASELISA TEST KIT | M.A. Bioproducts | 1982-07-30 |
Legacy Summary#
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FDA Review#
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