Company ยท US
Genetic Systems Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1989. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JTC | Device, Microtiter Diluting/Dispensing | 4 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 |
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | 2 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| LYF | Pneumocystis Carinii | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 25, 1989 | K891767 | GENETIC SYSTEMS MICROPLATE READER Genetic Systems Corp. | JJQ |
| May 1, 1989 | K891768 | GENETIC SYSTEMS MICROPLATE WASHER Genetic Systems Corp. | JTC |
| May 1, 1989 | K891766 | GENETIC SYSTEMS MICROPLATE STRIP WASHER Genetic Systems Corp. | JTC |
| May 1, 1989 | K891765 | GENETIC SYSTEMS PIPETTOR/DILUTOR Genetic Systems Corp. | JTC |
| Mar 21, 1989 | K890768 | PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT Genetic Systems Corp. | LYF |
| Nov 20, 1987 | K873564 | GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES Genetic Systems Corp. | LKT |
| Sep 23, 1987 | K873542 | MICROPLATE AUTO-WASHER (MOTORIZED STAGE) Genetic Systems Corp. | JTC |
| Jul 16, 1987 | K870176 | GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT Genetic Systems Corp. | LKT |
| Mar 19, 1987 | K870879 | ALANINE TRANSAMINASE (ALT) TEST KIT Genetic Systems Corp. | CKA |
| Oct 16, 1986 | K863566 | GSC 1000 Genetic Systems Corp. | JJQ |
| Aug 22, 1985 | K852237 | LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT Genetic Systems Corp. | LHL |
| Aug 2, 1984 | K842683 | GENETIC SYS LEGIONELLA IMMUNOFLURORES Genetic Systems Corp. | LHL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||