510(k) K974552
- Device
- DIAMEDIX IS-MEASLES IGG TEST SYSTEM
- Applicant
- DIAMEDIX CORP.
- 510(k) number
- K974552
- Product code
- LJB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-01-28
- Date received
- 1997-12-04
- Regulation
- 866.3520
- Classification name
- Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYNNE STIRLING
- Address
- 2140 N. Miami Ave. Miami FL US 33127 33127
FDA Registration Numbers#
- 3002800697
- 3005542422
- 9610240
- 3007361513
- 3008191245
- 1318354
- 9615056
- 8020790
- 3003268355
- 2242436
- 3007208259
- 2133982
- 2245285
- 1641328
- 3032705
- 2090110
- 3007118747
- 2915274
Source Documents#
Other 510(k) Records For Product Code LJB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K873925 | VIRGO(TM) MEASLES IGG ELISA | Electro-Nucleonics Laboratories, Inc. | 1988-02-24 |
| K821762 | MEASELISA TEST KIT | M.A. Bioproducts | 1982-07-30 |
Legacy Summary#
summary
FDA Review#
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