Toa Medical Electronics USA, Inc.
Mchenry, IL, US
Toa Medical Electronics USA, Inc. appears in FDA device records in Mchenry, IL. FDA records list 33 510(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
- 33
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 33 510(k) clearances for Toa Medical Electronics USA, Inc. between 1978 and 1994. The busiest year on record is 1991, with 6. The most recent is 1994, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 4 |
| 1982 | 1 |
| 1983 | 4 |
| 1984 | 1 |
| 1985 | 4 |
| 1986 | 2 |
| 1987 | 2 |
| 1988 | 4 |
| 1989 | 1 |
| 1991 | 6 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K936023 | SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent | |
| K933886 | TOA MEDICAL ELECTRONICS CA-5000 | JPA | Substantially Equivalent | |
| K931149 | CA-1000 AUTOMATED COAGULATION ANALYZER | JPA | Substantially Equivalent | |
| K920544 | SYSMEX HEMATOLOGY SYSTEM ACCESSORIES | GKZ | Substantially Equivalent | |
| K914744 | SYSMEX NE-1500, MODIFICATION | GKZ | Substantially Equivalent | |
| K912494 | SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER | GKL | Substantially Equivalent | |
| K911173 | SYSMEX F-310 | GKL | Substantially Equivalent | |
| K911172 | SYSMEX F-610 | GKL | Substantially Equivalent | |
| K910849 | SYSMEX F-810 | GKL | Substantially Equivalent | |
| K910745 | HEMOGLOBIN REAGENT | GKR | Substantially Equivalent | |
| K894539 | SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER | GKL | Substantially Equivalent | |
| K883997 | SYSMEX NE-8000 | GKZ | Substantially Equivalent | |
| K882370 | SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER | GKZ | Substantially Equivalent | |
| K882767 | SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM | GKH | Substantially Equivalent | |
| K882267 | SYSMEX QUICKLYSER-II (QLS-200A) | GIF | Substantially Equivalent | |
| K873734 | SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER | GKZ | Substantially Equivalent | |
| K871600 | SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY. | GKZ | Substantially Equivalent | |
| K855117 | SYSMEX E-2500 AUTOMATED HEMATOLOGY SYSTEM | GKZ | Substantially Equivalent | |
| K855116 | SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM | GKZ | Substantially Equivalent | |
| K850354 | SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS | GKZ | Substantially Equivalent | |
| K850171 | SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS | GKL | Substantially Equivalent | |
| K850239 | SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- | GIF | Substantially Equivalent | |
| K844910 | SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE - | GKZ | Substantially Equivalent | |
| K834021 | SYSMEX CC-780 EIGHT PARAMETER AUT0 | Substantially Equivalent | ||
| K830507 | SYSMEX CC-170 | GKL | Substantially Equivalent | |
| K830508 | SYSMEX CC-180 | GKL | Substantially Equivalent | |
| K830506 | SYSMEX CC-150 | GKL | Substantially Equivalent | |
| K830505 | SYSMEX CC-130 | GKL | Substantially Equivalent | |
| K822758 | SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY | GKL | Substantially Equivalent | |
| K780911 | SYSMEX PLATELET COUNTER, PL-110 | GKL | Substantially Equivalent | |
| K780910 | SYSTEM AUTO. BLOOD CELL COUNTER CC-110 | GKL | Substantially Equivalent | |
| K780909 | SYSMEX AUTO. BLOOD CELL COUNTER, CC-120 | GKL | Substantially Equivalent | |
| K780224 | MICROCELL COUNTER MODEL CC-108 | GKL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Toa Medical Electronics USA, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Toa Medical Electronics USA, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain