Immuno-Products Industries
Mchenry, IL, US
Immuno-Products Industries appears in FDA device records in Mchenry, IL. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Immuno-Products Industries between 1981 and 1985. The busiest year on record is 1981, with 5. The most recent is 1985, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 5 |
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 1 |
| 1985 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K853122 | IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED | GMS | Substantially Equivalent | |
| K852231 | ANA/LITE-HEP-2 TEST SYSTEM | LJM | Substantially Equivalent | |
| K852230 | ANA/LITE-RL TEST SYSTEM | LJM | Substantially Equivalent | |
| K843613 | FLUORESCENT TREPONEMEL ANTIBODY-ABSORB | GMS | Substantially Equivalent | |
| K831054 | ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB | DHN | Substantially Equivalent | |
| K830652 | ANTI N DNA-HCP | KTL | Substantially Equivalent | |
| K821576 | ANTINUCLEAR ANTIBODY SCREEN FLOURESC | DBL | Substantially Equivalent | |
| K810985 | ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT | DHN | Substantially Equivalent | |
| K810984 | ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST | DBM | Substantially Equivalent | |
| K810983 | ANTISMOOTH MUSCLE ANTIBODY TEST SYS | DBE | Substantially Equivalent | |
| K810982 | ANTITHYROID ANTIBODY IMMUNOFLUORESCENT | JZO | Substantially Equivalent | |
| K810981 | ANTI NDNA IMMUNOFLOURESCENT TEST SYS | DHC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTLAnti-Dna Indirect Immunofluorescent Solid Phase
- GMSAnti-Human Globulin, Fta-Abs Test
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- DBEAntismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
- DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- DHCSystem, Test, Systemic Lupus Erythematosus
- JZOSystem, Test, Thyroid Autoantibody
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain