Company ยท US
Labsystems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1993. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 5 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 5 |
| GQI | Antiserum, Cf, Cytomegalovirus | 2 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 |
| ITI | Wheelchair, Powered | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| KHE | Reagent, Occult Blood | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 24, 1993 | K923365 | TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEM Labsystems, Inc. | ITI |
| Jan 25, 1990 | K896474 | RESUBMITTED FECATWIN SENSITIVE - FECA-EIA Labsystems, Inc., FI | KHE |
| Feb 7, 1989 | K890154 | MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA Labsystems, Inc., FI | LGD |
| Feb 3, 1989 | K890091 | MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT Labsystems, Inc., FI | LFX |
| Apr 4, 1988 | K881243 | RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201 Labsystems, Inc. | LFX |
| Oct 15, 1987 | K873780 | MODIFICATION RUBELLA IGM EIA TEST KIT Labsystems, Inc. | LFX |
| Sep 22, 1987 | K873583 | AUTO-EIA Labsystems, Inc. | JJQ |
| Jul 1, 1987 | K872252 | MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT Labsystems, Inc. | LGD |
| Oct 1, 1986 | K862705 | CYTOMEGALOVIRUS IGG EIA TEST KIT Labsystems, Inc. | GQI |
| Aug 8, 1986 | K862431 | RUBELLA IGM EIA TEST KIT Labsystems, Inc. | LFX |
| Jun 30, 1986 | K862216 | TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) Labsystems, Inc. | LGD |
| Jun 17, 1986 | K853696 | RUBELLA IGG EIA TEST KIT Labsystems, Inc. | LFX |
| Jan 8, 1986 | K843189 | CYTOMEGALOVIRUS IGG EIA TEST KIT Labsystems, Inc. | GQI |
| Oct 17, 1984 | K842797 | TOXOPLASMA GONDII IGM EIA TEST KIT Labsystems, Inc. | LGD |
| Sep 4, 1984 | K842773 | LABSYSTEMS FP-901 CHEMISTRY ANALYZER Labsystems, Inc. | JJE |
| Apr 24, 1984 | K833829 | TOXOPLASMA GOND II IGG DIA TEST KIT Labsystems, Inc. | LGD |
| Apr 13, 1984 | K841214 | LABSYSTEMS UNISKAN Labsystems, Inc. | JJQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||