Company ยท US
Kent Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1995. Name variants (Inc, Corp, punctuation) are merged.
40510(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 | 5 |
| DDB | Ceruloplasmin, Antigen, Antiserum, Control | 3 |
| DFK | Igg (Fab Fragment Specific), Antigen, Antiserum, Control | 3 |
| DAS | Igg (Fc Fragment Specific), Antigen, Antiserum, Control | 2 |
| DFZ | Igg (Gamma Chain Specific), Antigen, Antiserum, Control | 2 |
| JZJ | Prealbumin, Antigen, Antiserum, Control | 2 |
| MSJ | Apolipoproteins | 2 |
| CZJ | Igd, Antigen, Antiserum, Control | 1 |
| CZP | Iga, Antigen, Antiserum, Control | 1 |
| CZX | Hemopexin, Antigen, Antiserum, Control | 1 |
| DAD | Haptoglobin, Antigen, Antiserum, Control | 1 |
| DAK | Complement C1q, Antigen, Antiserum, Control | 1 |
| DAO | Igm (Mu Chain Specific), Antigen, Antiserum, Control | 1 |
| DAY | Complement C5, Antigen, Antiserum, Control | 1 |
| DBA | Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 |
| DBY | Fab, Rhodamine, Antigen, Antiserum, Control | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
| DCN | System, Test, C-Reactive Protein | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 1, 1995 | K951966 | HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT Kent Laboratories, Inc. | JZJ |
| May 30, 1995 | K951968 | HUMAN C1Q RADIAL IMMUNODIFFUSION KIT Kent Laboratories, Inc. | DAK |
| May 30, 1995 | K951967 | HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT Kent Laboratories, Inc. | DBA |
| Apr 10, 1995 | K950102 | HUMAN C-5 RADIAL IMMUNODIFFUSION KIT Kent Laboratories, Inc. | DAY |
| Nov 27, 1985 | K850683 | 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 Kent Laboratories, Inc. | DEB |
| Nov 25, 1985 | K850682 | 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL Kent Laboratories, Inc. | DDB |
| Nov 1, 1985 | K850691 | ANTISERUM TO HUMAN APOLIPOPROTEIN A-I Kent Laboratories, Inc. | MSJ |
| Nov 1, 1985 | K850690 | ANTISERUM TO HUMAN APOLIPOPROTEIN B Kent Laboratories, Inc. | MSJ |
| Nov 1, 1985 | K850686 | ANTISERUM TO HUMAN PREALBUMIN Kent Laboratories, Inc. | JZJ |
| Aug 11, 1983 | K831961 | IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN Kent Laboratories, Inc. | JBQ |
| Jul 19, 1983 | K831960 | TEST FOR HUMAN ALPHA ONE ACID GLYCO- Kent Laboratories, Inc. | LKL |
| Jul 19, 1983 | K831959 | RADIAL IMMUNO-TEST FOR HUMAN FACTOR B Kent Laboratories, Inc. | JZH |
| Jul 19, 1983 | K831958 | RADIAL IMMUNO-TEST FOR HUMAN C-REACTI Kent Laboratories, Inc. | DCK |
| Jul 18, 1983 | K831957 | DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB Kent Laboratories, Inc. | DAD |
| Jul 18, 1983 | K831956 | DETERM. SIZE 72 RADIAL-HUMAN IGD Kent Laboratories, Inc. | CZJ |
| Dec 30, 1982 | K823765 | ANTI SERA TO HUMAN OROSCOMUCOID Kent Laboratories, Inc. | DEX |
| Sep 30, 1982 | K822472 | ANTISERA TO HUMAN FERRITIN Kent Laboratories, Inc. | DBF |
| Aug 12, 1981 | K811613 | 72 DETERMIN. SIZE RADIAL IMMUNOD. TEST Kent Laboratories, Inc. | DDG |
| Sep 12, 1979 | K790706 | ANTISERUM TO RABBIT IGG H & L CHAIN Kent Laboratories, Inc. | DFH |
| Sep 4, 1979 | K790713 | ANTISERUM TO HUMAN HEMOPEXIN Kent Laboratories, Inc. | CZX |
| Sep 4, 1979 | K790711 | ANTISERA TO HUMAN FRAGMENT Kent Laboratories, Inc. | DFK |
| Sep 4, 1979 | K790702 | ANTISERUM, HUMAN, IGG H & L CHAIN Kent Laboratories, Inc. | DEW |
| Aug 22, 1979 | K790708 | ANTISERUM TO HUMAN IG G FC FRAGMENTS Kent Laboratories, Inc. | DAS |
| Aug 16, 1979 | K790720 | ANTISERA TO RABBIT IMMUNOGLOBULIN Kent Laboratories, Inc. | DFZ |
| Aug 16, 1979 | K790715 | ANTISERUM TO HUMAN FC Kent Laboratories, Inc. | DAS |
| Aug 16, 1979 | K790714 | ANTISERUM TO HUMAN CERULOPLASMIN Kent Laboratories, Inc. | DDB |
| Aug 16, 1979 | K790712 | ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI Kent Laboratories, Inc. | DDB |
| Aug 16, 1979 | K790709 | ANTISERUM TO RABBIT IMMUNOGLOBULIN Kent Laboratories, Inc. | DFZ |
| Aug 3, 1979 | K790716 | ANTISERUM TO HUMAN C-REACTIVE PROTEINS Kent Laboratories, Inc. | DCN |
| Aug 3, 1979 | K790710 | ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN Kent Laboratories, Inc. | DDY |
| Apr 12, 1979 | K790705 | ANTISERUM TO HUMAN IGM Kent Laboratories, Inc. | DAO |
| Apr 12, 1979 | K790704 | ANTISERUM TO HUMAN IGG Kent Laboratories, Inc. | DEW |
| Apr 12, 1979 | K790703 | ANTISERUM, HUMAN, IGA Kent Laboratories, Inc. | CZP |
| Aug 3, 1977 | K771243 | ANTISERA TO HUMAN FAB FRAGMENT Kent Laboratories, Inc. | DFK |
| Aug 3, 1977 | K771242 | ANTISERA TO HUMAN FAB FRAGMENT Kent Laboratories, Inc. | DDR |
| Jul 14, 1977 | K771144 | RHODAMINE-CONJUGATED ANTISERUM Kent Laboratories, Inc. | DBY |
| Apr 28, 1977 | K770670 | FLOR. CONJUG. HUMAN FAB FRAGMENT Kent Laboratories, Inc. | DFK |
| Apr 28, 1977 | K770669 | RHODAMINE-CONJUGATED ANTISERUM Kent Laboratories, Inc. | DEW |
| Apr 28, 1977 | K770668 | FLUORESCEIN CONJUGATED ANTISERUM Kent Laboratories, Inc. | DEW |
| Mar 21, 1977 | K770484 | FLUOR. CONJUGATED ANTISERUM Kent Laboratories, Inc. | DEW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||