510(k) K872910
- Device
- IMMUNO/SLE
- Applicant
- IMMUNOSTICS CO., INC.
- 510(k) number
- K872910
- Product code
- DHC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-08-12
- Date received
- 1987-07-24
- Regulation
- 866.5820
- Classification name
- System, Test, Systemic Lupus Erythematosus
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH KUPITS
- Address
- 3505 Sunset Ave. Ocean NJ US 07712 07712
FDA Registration Numbers#
- 1832216
- 1641328
- 2242436
- 2029372
- 1721937
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DHC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K001352 | REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | Corgenix, Inc. | 2001-04-09 |
| K001398 | REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | Corgenix, Inc. | 2001-03-30 |
| K930247 | HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE | The Binding Site, Ltd. | 1993-03-10 |
| K930421 | ELIAS DSDNA ABS | Elias U.S.A., Inc. | 1993-03-10 |
| K914801 | IMMUNOWELL DSDNA ANTIBODY TEST | General Biometrics, Inc. | 1991-12-09 |
| K885048 | ACCESS R-CLONE ANA PROFILE ASSAY | Lipogen, Inc. | 1989-01-24 |
| K821385 | SERO/TEX LE TEST | Texas Immunology, Inc. | 1982-05-28 |
| K810981 | ANTI NDNA IMMUNOFLOURESCENT TEST SYS | Immuno-Products Industries | 1981-04-29 |
| K810226 | SLE ANTI-N-DNA LATEX TEST | Icl Scientific | 1981-02-09 |
| K800991 | CORDIA N | Cordis Corp. | 1980-05-08 |
| K800992 | CORDIA NP | Cordis Corp. | 1980-05-08 |
| K800605 | ANA LATEX SLIDE TEST | Biologics Intl., Inc. | 1980-04-02 |
| K790106 | IIF-A-N-DNA TEST KIT | Medica Corp. | 1979-03-15 |
| K790257 | SYSTEMIC LUPUS | Icl Scientific | 1979-03-15 |
| K782129 | LUPO-TEC | Armkel, LLC | 1979-03-12 |
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