Company ยท US
Atlantic Antibodies
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1989. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MSJ | Apolipoproteins | 4 |
| CZP | Iga, Antigen, Antiserum, Control | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 |
| JZJ | Prealbumin, Antigen, Antiserum, Control | 2 |
| CFQ | Radioimmunoassay, Immunoglobulins (G, A, M) | 1 |
| DAD | Haptoglobin, Antigen, Antiserum, Control | 1 |
| DBI | Complement C4, Antigen, Antiserum, Control | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| KTQ | Reagent, Complement | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 9, 1989 | K892526 | SPQ TM TEST SYSTEM II FOR CRP Atlantic Antibodies | DCK |
| Mar 16, 1989 | K891154 | SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B Atlantic Antibodies | MSJ |
| Mar 3, 1989 | K890563 | SPQ(TM) ANTIBODY REAGENT SET II FOR TRF Atlantic Antibodies | DDG |
| Feb 23, 1989 | K890561 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGM Atlantic Antibodies | CFQ |
| Feb 22, 1989 | K890562 | SPQ(TM) ANTIBODY REAGENT SET II FOR HPT Atlantic Antibodies | DAD |
| Feb 22, 1989 | K890416 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGG Atlantic Antibodies | DEW |
| Feb 17, 1989 | K890564 | SPQ(TM) ANTIBODY REAGENT SET II FOR C4 Atlantic Antibodies | DBI |
| Feb 17, 1989 | K890417 | SPQ(TM) ANTIBODY REAGENT SET II FOR C3 Atlantic Antibodies | KTQ |
| Feb 17, 1989 | K890415 | SPQ(TM) ANTIBODY REAGENT SET II FOR AAT Atlantic Antibodies | DEM |
| Feb 15, 1989 | K890560 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGA Atlantic Antibodies | CZP |
| Nov 2, 1988 | K884298 | SPQ(TM) TEST SYSTEM FOR MICROALBUMIN Atlantic Antibodies | JZJ |
| Nov 2, 1988 | K884297 | SPQ(TM) TEST SYSTEM FOR PREALBUMIN Atlantic Antibodies | JZJ |
| Jun 14, 1988 | K881898 | MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B Atlantic Antibodies | MSJ |
| Mar 24, 1987 | K870862 | SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL Atlantic Antibodies | MSJ |
| Mar 24, 1987 | K870564 | SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B Atlantic Antibodies | MSJ |
| Apr 25, 1986 | K861167 | IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST Atlantic Antibodies | CZP |
| Jun 5, 1985 | K851842 | SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN Atlantic Antibodies | DCK |
| Nov 21, 1983 | K833119 | AUTOIMMUNE TEST 1/2/3 SYSTEM Atlantic Antibodies | DHN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||