Company ยท US
Apple Diagnostic Products
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1985. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 |
| GLZ | Antigens, If, Toxoplasma Gondii | 1 |
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | 1 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 1 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 1 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 7, 1985 | K844287 | ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII Apple Diagnostic Products | GLZ |
| Oct 25, 1984 | K843745 | ADP ANA APPLEZYME Apple Diagnostic Products | LJM |
| Sep 12, 1984 | K843120 | APPLELISA CHLAMYDIA TRACHOMATIS ANTI Apple Diagnostic Products | LJC |
| Aug 21, 1984 | K842707 | ADP NDNA IFA TEST Apple Diagnostic Products | KTL |
| Jun 22, 1984 | K842183 | ADP ANA IFA TEST Apple Diagnostic Products | DHN |
| Apr 4, 1984 | K834241 | ANA APPLELISA Apple Diagnostic Products | DHN |
| Mar 2, 1984 | K834242 | ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS Apple Diagnostic Products | LJP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||