Company ยท US
Immunotech Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1995. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GKZ | Counter, Differential Cell | 6 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 3 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 3 |
| CDX | Radioimmunoassay, Total Thyroxine | 2 |
| CEC | Radioimmunoassay, Free Thyroxine | 2 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 2 |
| CGI | Radioimmunoassay, Estriol | 2 |
| KLS | Enzyme Immunoassay, Theophylline | 2 |
| KXT | Enzyme Immunoassay, Digoxin | 2 |
| CDA | Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 |
| DLZ | Enzyme Immunoassay, Phenobarbital | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 3, 1995 | K954188 | OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL Immunotech Corp. | GKZ |
| Oct 20, 1995 | K946335 | OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES Immunotech, Inc. | GKZ |
| Sep 8, 1995 | K953498 | OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL Immunotech, Inc. | GKZ |
| Aug 14, 1995 | K952789 | OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES Immunotech Corp. | GKZ |
| Jul 5, 1995 | K952182 | OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES Immunotech, Inc. | GKZ |
| May 5, 1995 | K950626 | OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES Immunotech Corp. | GKZ |
| Nov 16, 1993 | K934012 | FT4 RADIOIMMUNOASSAY Immunotech S.A., FR | CEC |
| Oct 22, 1993 | K931228 | PROGESTERONE RADIOIMMUNOASSAY KIT Immunotech Corp., FR | JLS |
| Jun 24, 1991 | K911634 | MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST Immunotech Corp. | CEC |
| Jun 18, 1991 | K911153 | MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT Immunotech Corp. | LCM |
| Apr 3, 1991 | K910411 | MICROZYME TSH ENZYME IMMUNOASSAY KIT Immunotech Corp. | JLW |
| Jan 30, 1991 | K905777 | MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT Immunotech Corp. | CEE |
| Dec 20, 1990 | K903993 | MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT Immunotech Corp. | DKZ |
| Dec 18, 1990 | K904820 | MICROZYME T3 ENZYME IMMUNOASSAY KIT Immunotech Corp. | CDP |
| Nov 1, 1990 | K904635 | MICROZYME THC ENZYME IMMUNOASSAY TEST KIT Immunotech Corp. | LDJ |
| Oct 26, 1990 | K903725 | EZ-BEAD TSH ENZYME IMMUNOASSAY KIT Immunotech Corp. | JLW |
| Oct 22, 1990 | K903609 | SEROTONIN ENZYME IMMUNOASSAY Immunotech Corp., FR | CDA |
| Aug 22, 1990 | K903359 | MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT Immunotech Corp. | CGI |
| Jul 27, 1990 | K902922 | MICROZYME T4 ENZYME IMMUNOASSAY KIT Immunotech Corp. | CDX |
| Jul 17, 1990 | K902194 | MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT Immunotech Corp. | DJG |
| May 17, 1990 | K901080 | EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT Immunotech Corp. | DIP |
| Mar 23, 1990 | K896781 | MICRO DAU COCAINE METABOLITE TEST KIT Immunotech Corp. | DIO |
| Mar 23, 1990 | K896780 | MICRO DAU BENZODIAZEPINE ENZYME IMMUNOASSAY KIT Immunotech Corp. | JXM |
| Mar 9, 1990 | K900036 | IMMUNOTECH HDL-CHOLESTEROL TEST Immunotech Corp. | LBS |
| Mar 6, 1990 | K897036 | IMMUNOTECH CHOLESTEROL TEST Immunotech Corp. | CHH |
| Sep 28, 1989 | K893843 | EZ-BEAD DIGOXIN EIA KIT Immunotech Corp. | KXT |
| May 27, 1988 | K881257 | EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT Immunotech Corp. | KLS |
| Aug 17, 1987 | K872172 | IMMUBEAD THYROID UPTAKE Immunotech Corp. | KHQ |
| Aug 13, 1987 | K872192 | IMMUBEAD T4 ENZYME IMMUNOASSAY KIT Immunotech Corp. | KLI |
| Aug 13, 1987 | K872191 | IMMUBEAD T3 ENZYME IMMUNOASSAY KIT Immunotech Corp. | CDP |
| Aug 12, 1985 | K852995 | ENDAB PHENOBARBITAL Immunotech Corp. | DLZ |
| May 31, 1985 | K851980 | ENDAB TSH Immunotech Corp. | JLW |
| Apr 18, 1984 | K840902 | ENDAB ESTRIOL UNCONJUGATED Immunotech Corp. | CGI |
| Jan 30, 1984 | K834049 | ENDAB T3 Immunotech Corp. | CDP |
| Oct 8, 1982 | K822684 | ENDAB THYROID UPTAKE Immunotech Corp. | CEE |
| May 13, 1982 | K821141 | ENDAB T4 ENZYME IMMUNOASSAY KIT Immunotech Corp. | CDX |
| Aug 12, 1981 | K812054 | ENDAB DIGOXIN KIT Immunotech Corp. | KXT |
| Feb 6, 1981 | K810192 | ENDAB CORTISOL KIT Immunotech Corp. | CGR |
| Jan 16, 1981 | K803296 | ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT Immunotech Corp. | KWW |
| Oct 31, 1980 | K802461 | ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT Immunotech Corp. | LCW |
| Oct 23, 1980 | K802066 | ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY Immunotech Corp. | KLS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||