510(k) K001767
- Device
- DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM
- Applicant
- DIAMEDIX CORP.
- 510(k) number
- K001767
- Product code
- LJO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-08-07
- Date received
- 2000-06-12
- Regulation
- 866.3175
- Classification name
- Antigen, Iha, Cytomegalovirus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- 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#
- 1034569
Source Documents#
Other 510(k) Records For Product Code LJO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203612 | Capture-CMV | Immucor, Inc. | 2021-03-22 |
| K183571 | Capture-CMV | Immucor, Inc. | 2019-02-04 |
| K974901 | HYBRID CAPTURE SYSTEM CMV DNA ASSAY | Digene Corp. | 1998-09-29 |
| K974456 | CMVGEN | Instrumentation Laboratory CO | 1998-05-01 |
| K951851 | ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY | E.I. Dupont DE Nemours & Co., Inc. | 1996-07-24 |
| K955799 | COPALIS CMV TOTAL ANTIBODY ASSAY | Sienna Biotech, Inc. | 1996-07-10 |
| K920222 | HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS | Akers Research Corp. | 1992-07-27 |
| K910003 | CYTOMEGALOVIRUS ANTIBODY SCREEN | Immucor, Inc. | 1991-03-20 |
| K852494 | CMV-IHA | Hillcrest Biologicals | 1985-09-16 |
| K841520 | CMV LATEX AGGLUTINATION TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-09-07 |
| K822965 | CETUS CMV IHA | Cetus Corp. | 1983-02-15 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases