Company ยท US
Toa Medical Electronics USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1994. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 2, 1994 | K936023 | SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER Toa Medical Electronics USA, Inc. | GKZ |
| Jan 27, 1994 | K933886 | TOA MEDICAL ELECTRONICS CA-5000 Toa Medical Electronics USA, Inc. | JPA |
| Nov 3, 1993 | K931149 | CA-1000 AUTOMATED COAGULATION ANALYZER Toa Medical Electronics USA, Inc. | JPA |
| Apr 29, 1992 | K920544 | SYSMEX HEMATOLOGY SYSTEM ACCESSORIES Toa Medical Electronics USA, Inc. | GKZ |
| Dec 30, 1991 | K914744 | SYSMEX NE-1500, MODIFICATION Toa Medical Electronics USA, Inc. | GKZ |
| Sep 10, 1991 | K912494 | SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER Toa Medical Electronics USA, Inc. | GKL |
| Jul 26, 1991 | K911173 | SYSMEX F-310 Toa Medical Electronics USA, Inc. | GKL |
| Jul 26, 1991 | K911172 | SYSMEX F-610 Toa Medical Electronics USA, Inc. | GKL |
| Jul 26, 1991 | K910849 | SYSMEX F-810 Toa Medical Electronics USA, Inc. | GKL |
| Jul 11, 1991 | K910745 | HEMOGLOBIN REAGENT Toa Medical Electronics USA, Inc. | GKR |
| Sep 26, 1989 | K894539 | SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER Toa Medical Electronics USA, Inc. | GKL |
| Dec 5, 1988 | K883997 | SYSMEX NE-8000 Toa Medical Electronics USA, Inc. | GKZ |
| Aug 25, 1988 | K882370 | SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER Toa Medical Electronics USA, Inc. | GKZ |
| Jul 18, 1988 | K882767 | SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM Toa Medical Electronics USA, Inc. | GKH |
| Jul 12, 1988 | K882267 | SYSMEX QUICKLYSER-II (QLS-200A) Toa Medical Electronics USA, Inc. | GIF |
| Nov 25, 1987 | K873734 | SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER Toa Medical Electronics USA, Inc. | GKZ |
| Jun 24, 1987 | K871600 | SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY. Toa Medical Electronics USA, Inc. | GKZ |
| Feb 24, 1986 | K855117 | SYSMEX E-2500 AUTOMATED HEMATOLOGY SYSTEM Toa Medical Electronics USA, Inc. | GKZ |
| Feb 24, 1986 | K855116 | SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM Toa Medical Electronics USA, Inc. | GKZ |
| May 20, 1985 | K850354 | SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS Toa Medical Electronics USA, Inc. | GKZ |
| May 13, 1985 | K850171 | SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS Toa Medical Electronics USA, Inc. | GKL |
| Apr 1, 1985 | K850239 | SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- Toa Medical Electronics USA, Inc. | GIF |
| Apr 1, 1985 | K844910 | SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE - Toa Medical Electronics USA, Inc. | GKZ |
| Mar 2, 1984 | K834021 | SYSMEX CC-780 EIGHT PARAMETER AUT0 Toa Medical Electronics USA, Inc. | |
| May 13, 1983 | K830507 | SYSMEX CC-170 Toa Medical Electronics USA, Inc. | GKL |
| May 9, 1983 | K830508 | SYSMEX CC-180 Toa Medical Electronics USA, Inc. | GKL |
| May 9, 1983 | K830506 | SYSMEX CC-150 Toa Medical Electronics USA, Inc. | GKL |
| May 9, 1983 | K830505 | SYSMEX CC-130 Toa Medical Electronics USA, Inc. | GKL |
| Oct 18, 1982 | K822758 | SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY Toa Medical Electronics USA, Inc. | GKL |
| Jun 28, 1978 | K780911 | SYSMEX PLATELET COUNTER, PL-110 Toa Medical Electronics USA, Inc. | GKL |
| Jun 28, 1978 | K780910 | SYSTEM AUTO. BLOOD CELL COUNTER CC-110 Toa Medical Electronics USA, Inc. | GKL |
| Jun 28, 1978 | K780909 | SYSMEX AUTO. BLOOD CELL COUNTER, CC-120 Toa Medical Electronics USA, Inc. | GKL |
| May 19, 1978 | K780224 | MICROCELL COUNTER MODEL CC-108 Toa Medical Electronics USA, Inc. | GKL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||