Amico Lab, Inc.
Mchenry, IL, US
Amico Lab, Inc. appears in FDA device records in Mchenry, IL. FDA records list 32 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 32
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 32 510(k) clearances for Amico Lab, Inc. between 1982 and 1985. The busiest year on record is 1982, with 16. The most recent is 1985, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 16 |
| 1984 | 10 |
| 1985 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K842662 | ANTI-EPSTEIN-BARR VIRUS KIT | GNP | Substantially Equivalent | |
| K842663 | ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 | GQO | Substantially Equivalent | |
| K842661 | ANTI-CYTOMEGALOVIRUS KIT | GQI | Substantially Equivalent | |
| K842531 | AMIZYME-HSV TYPES 1 & 2 TEST KITS | GQO | Substantially Equivalent | |
| K842530 | AMIZYME-EBV TEST KIT | GNP | Substantially Equivalent | |
| K842529 | AMIZYME-CMV KIT | GQI | Substantially Equivalent | |
| K842660 | ANTI-SCHISTOSOMA SPECIES KIT | GNH | Substantially Equivalent | |
| K842658 | ANTI-CHLAMYDIA TRACHOMATIS KIT | LJP | Substantially Equivalent | |
| K842525 | AMIZYME-C TRACHOMATIS TEST KIT | LJP | Substantially Equivalent | |
| K842533 | AMIZYME-ANDNA TEST KIT | LJM | Substantially Equivalent | |
| K842532 | AMIZYME-ANA TEST KIT | LJM | Substantially Equivalent | |
| K842528 | AMIZYME-TOXOPLASMA GONDII KIT | LGD | Substantially Equivalent | |
| K842527 | AMIZYME-SCHISTOSOMA SPP. TEST KIT | GNH | Substantially Equivalent | |
| K842664 | ANTI-TOXOPLASMA GONDII KIT | GLZ | Substantially Equivalent | |
| K842526 | AMIZYME-LEISHMANIA SPP. TEST KIT | LOO | Substantially Equivalent | |
| K840024 | WHEELCHAIR MECHANICAL | IOR | Substantially Equivalent | |
| K822681 | ANTI-NUCLEAR ANTIBODY TEST KIT (ANA) | DHN | Substantially Equivalent | |
| K822682 | ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K | DHN | Substantially Equivalent | |
| K823121 | RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA | DFH | Substantially Equivalent | |
| K822679 | FITC ANTISERA TO HUMAN C3 | DFH | Substantially Equivalent | |
| K822678 | FITC ANTISERA TO HUMAN GOBULIN | DFH | Substantially Equivalent | |
| K822677 | FITC ANTISERA TO HUMAN IGM | DFH | Substantially Equivalent | |
| K822676 | FITC ANTISERA TO HUMAN IGG | DFH | Substantially Equivalent | |
| K822675 | FITC ANTISERA TO HUMAN IGA | DFH | Substantially Equivalent | |
| K822674 | FITC ANTISERA TO HUMAN LAMBDA | DFH | Substantially Equivalent | |
| K822673 | FITC ANTISERA TO HUMAN KAPPA | DFH | Substantially Equivalent | |
| K822671 | ANTISERUM TO HUMAN GOBULIN | DFH | Substantially Equivalent | |
| K822670 | ANTISERUM TO HUMAN IGM | DFH | Substantially Equivalent | |
| K822669 | ANTISERUM TO HUMAN IGG | DFH | Substantially Equivalent | |
| K822668 | ANTISERUM TO HUMAN IGA | DFH | Substantially Equivalent | |
| K822667 | ANTISERUM TO HUMAN LAMBDA | DFH | Substantially Equivalent | |
| K822666 | ANTISERUM TO HUMAN KAPPA | DFH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GNHAntigen, Fluorescent Antibody Test, Schistosoma Mansoni
- GLZAntigens, If, Toxoplasma Gondii
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- GQOAntisera, Cf, Herpesvirus Hominis 1,2
- GQIAntiserum, Cf, Cytomegalovirus
- GNPAntiserum, Cf, Epstein-Barr Virus
- LJPAntiserum, Fluorescent, Chlamydia Trachomatis
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- DFHKappa, Antigen, Antiserum, Control
- LOOReagent, Leishmanii Serological
- IORWheelchair, Mechanical
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain