Diagnostica, Inc. FDA Record
- No warning letters matched by name
Diagnostica, Inc. has 0 FDA recalls, 0 inspections, 12 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Diagnostica, Inc." is on file.
- Latest 510(k)
- Feb 23, 2001
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 12 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 0 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K002756 | EASE-A-CULT | Feb 23, 2001 |
| K823348 | H. INFLUENZA B ANTISERA FOR CIE | Dec 28, 1982 |
| K812434 | DIAGNOSTIC KITS & KIT COMPONENTS | Sep 23, 1981 |
| K800398 | PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT | Mar 12, 1980 |
| K791284 | ANTI-HUMAN KAPPA SERUM | Nov 27, 1979 |
| K791283 | ANTI-HUMAN LAMBDA SERUM | Nov 27, 1979 |
| K791281 | ANTI-HUMAN IGG SERUM | Nov 27, 1979 |
| K791285 | ANTI-HUMAN GLOBULINS | Oct 17, 1979 |
| K791282 | ANTI-HUMAN SERUM | Oct 17, 1979 |
| K790671 | DERMATOPHYTIN O | May 31, 1979 |
| K790672 | ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU | May 31, 1979 |
| K781710 | BUFFER, COLLAGEN REAGENT AND DILUENT | Oct 24, 1978 |
Diagnostica, Inc. and the FDA: common questions
Has Diagnostica, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Diagnostica, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Diagnostica, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Diagnostica, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
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