Company ยท US
Amico Lab, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 1985. Name variants (Inc, Corp, punctuation) are merged.
32510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DFH | Kappa, Antigen, Antiserum, Control | 14 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 |
| GNH | Antigen, Fluorescent Antibody Test, Schistosoma Mansoni | 2 |
| GNP | Antiserum, Cf, Epstein-Barr Virus | 2 |
| GQI | Antiserum, Cf, Cytomegalovirus | 2 |
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 2 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 2 |
| GLZ | Antigens, If, Toxoplasma Gondii | 1 |
| IOR | Wheelchair, Mechanical | 1 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 1 |
| LOO | Reagent, Leishmanii Serological | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 12, 1985 | K842662 | ANTI-EPSTEIN-BARR VIRUS KIT Amico Lab, Inc. | GNP |
| Dec 6, 1985 | K842663 | ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 Amico Lab, Inc. | GQO |
| Dec 6, 1985 | K842661 | ANTI-CYTOMEGALOVIRUS KIT Amico Lab, Inc. | GQI |
| Dec 6, 1985 | K842531 | AMIZYME-HSV TYPES 1 & 2 TEST KITS Amico Lab, Inc. | GQO |
| Dec 6, 1985 | K842530 | AMIZYME-EBV TEST KIT Amico Lab, Inc. | GNP |
| Dec 6, 1985 | K842529 | AMIZYME-CMV KIT Amico Lab, Inc. | GQI |
| Oct 30, 1984 | K842660 | ANTI-SCHISTOSOMA SPECIES KIT Amico Lab, Inc. | GNH |
| Oct 1, 1984 | K842658 | ANTI-CHLAMYDIA TRACHOMATIS KIT Amico Lab, Inc. | LJP |
| Oct 1, 1984 | K842525 | AMIZYME-C TRACHOMATIS TEST KIT Amico Lab, Inc. | LJP |
| Sep 20, 1984 | K842533 | AMIZYME-ANDNA TEST KIT Amico Lab, Inc. | LJM |
| Sep 20, 1984 | K842532 | AMIZYME-ANA TEST KIT Amico Lab, Inc. | LJM |
| Sep 7, 1984 | K842528 | AMIZYME-TOXOPLASMA GONDII KIT Amico Lab, Inc. | LGD |
| Sep 5, 1984 | K842527 | AMIZYME-SCHISTOSOMA SPP. TEST KIT Amico Lab, Inc. | GNH |
| Aug 28, 1984 | K842664 | ANTI-TOXOPLASMA GONDII KIT Amico Lab, Inc. | GLZ |
| Aug 28, 1984 | K842526 | AMIZYME-LEISHMANIA SPP. TEST KIT Amico Lab, Inc. | LOO |
| Jan 30, 1984 | K840024 | WHEELCHAIR MECHANICAL Amico Lab, Inc. | IOR |
| Dec 13, 1982 | K822681 | ANTI-NUCLEAR ANTIBODY TEST KIT (ANA) Amico Lab, Inc. | DHN |
| Dec 3, 1982 | K822682 | ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K Amico Lab, Inc. | DHN |
| Nov 17, 1982 | K823121 | RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA Amico Lab, Inc. | DFH |
| Nov 17, 1982 | K822679 | FITC ANTISERA TO HUMAN C3 Amico Lab, Inc. | DFH |
| Nov 17, 1982 | K822678 | FITC ANTISERA TO HUMAN GOBULIN Amico Lab, Inc. | DFH |
| Nov 17, 1982 | K822677 | FITC ANTISERA TO HUMAN IGM Amico Lab, Inc. | DFH |
| Nov 17, 1982 | K822676 | FITC ANTISERA TO HUMAN IGG Amico Lab, Inc. | DFH |
| Nov 17, 1982 | K822675 | FITC ANTISERA TO HUMAN IGA Amico Lab, Inc. | DFH |
| Nov 17, 1982 | K822674 | FITC ANTISERA TO HUMAN LAMBDA Amico Lab, Inc. | DFH |
| Nov 17, 1982 | K822673 | FITC ANTISERA TO HUMAN KAPPA Amico Lab, Inc. | DFH |
| Nov 17, 1982 | K822671 | ANTISERUM TO HUMAN GOBULIN Amico Lab, Inc. | DFH |
| Nov 17, 1982 | K822670 | ANTISERUM TO HUMAN IGM Amico Lab, Inc. | DFH |
| Nov 17, 1982 | K822669 | ANTISERUM TO HUMAN IGG Amico Lab, Inc. | DFH |
| Nov 17, 1982 | K822668 | ANTISERUM TO HUMAN IGA Amico Lab, Inc. | DFH |
| Nov 17, 1982 | K822667 | ANTISERUM TO HUMAN LAMBDA Amico Lab, Inc. | DFH |
| Nov 17, 1982 | K822666 | ANTISERUM TO HUMAN KAPPA Amico Lab, Inc. | DFH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||