Company ยท US
Diagnostica, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2001. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DEW | Igg, Antigen, Antiserum, Control | 3 |
| DEH | Lambda, Antigen, Antiserum, Control | 1 |
| DFH | Kappa, Antigen, Antiserum, Control | 1 |
| DGQ | Whole Blood Plasma, Antigen, Antiserum, Control | 1 |
| GRP | Antisera, All Types, H. Influenza | 1 |
| JBX | Aggregrometer, Platelet | 1 |
| JWT | Antigen, Cf, Aspergillus Spp. | 1 |
| JXB | Kit, Identification, Yeast | 1 |
| KHE | Reagent, Occult Blood | 1 |
| LHT | Staphylococcus Aureus Somatic Antigens | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 23, 2001 | K002756 | EASE-A-CULT Diagnostica, Inc. | KHE |
| Dec 28, 1982 | K823348 | H. INFLUENZA B ANTISERA FOR CIE Diagnostica, Inc. | GRP |
| Sep 23, 1981 | K812434 | DIAGNOSTIC KITS & KIT COMPONENTS Diagnostica, Inc. | LHT |
| Mar 12, 1980 | K800398 | PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT Diagnostica, Inc. | DEW |
| Nov 27, 1979 | K791284 | ANTI-HUMAN KAPPA SERUM Diagnostica, Inc. | DFH |
| Nov 27, 1979 | K791283 | ANTI-HUMAN LAMBDA SERUM Diagnostica, Inc. | DEH |
| Nov 27, 1979 | K791281 | ANTI-HUMAN IGG SERUM Diagnostica, Inc. | DEW |
| Oct 17, 1979 | K791285 | ANTI-HUMAN GLOBULINS Diagnostica, Inc. | DEW |
| Oct 17, 1979 | K791282 | ANTI-HUMAN SERUM Diagnostica, Inc. | DGQ |
| May 31, 1979 | K790672 | ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU Diagnostica, Inc. | JWT |
| May 31, 1979 | K790671 | DERMATOPHYTIN O Diagnostica, Inc. | JXB |
| Oct 24, 1978 | K781710 | BUFFER, COLLAGEN REAGENT AND DILUENT Diagnostica, Inc. | JBX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||