Company ยท US
Immuno-Diagnostic Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1986. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 |
| GLZ | Antigens, If, Toxoplasma Gondii | 1 |
| GNP | Antiserum, Cf, Epstein-Barr Virus | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 |
| JWL | Antigen, Treponema Pallidum For Fta-Abs Test | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 24, 1986 | K854207 | EBV(EPSTEIN-BARR VIRUS) TEST KIT Immuno-Diagnostic Products, Inc. | GNP |
| Nov 5, 1981 | K811021 | HERPES Immuno-Diagnostic Products, Inc. | GQN |
| Jul 16, 1981 | K811562 | TOXOPLASMOSIS TEST KIT Immuno-Diagnostic Products, Inc. | GLZ |
| Apr 23, 1981 | K811022 | ANA TEST KIT Immuno-Diagnostic Products, Inc. | DHN |
| Oct 23, 1980 | K801963 | CMV TEST KIT Immuno-Diagnostic Products, Inc. | GQH |
| Oct 23, 1980 | K801959 | FTA-ABS TEST Immuno-Diagnostic Products, Inc. | JWL |
| Oct 10, 1980 | K801961 | RF-II TEST KIT Immuno-Diagnostic Products, Inc. | DHR |
| Oct 10, 1980 | K801960 | ANTI-DS/N-DNA TEST KIT Immuno-Diagnostic Products, Inc. | DBL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||