Tosoh Medics, Inc.
South San Francisco, CA, US
Tosoh Medics, Inc. appears in FDA device records in South San Francisco, CA. FDA records list 41 510(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
- 41
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 41 510(k) clearances for Tosoh Medics, Inc. between 1990 and 2002. The busiest year on record is 1993, with 8. The most recent is 2002, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 6 |
| 1993 | 8 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 3 |
| 1997 | 5 |
| 1998 | 4 |
| 1999 | 3 |
| 2001 | 3 |
| 2002 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K023893 | ST AIA-PACK CEA ENZYME IMMUNOASSAY | DHX | Substantially Equivalent | |
| K023894 | ST AIA-PACK AFP ENZYME IMMUNOASSAY | LOJ | Substantially Equivalent | |
| K023091 | ST AIA-PACK TESTOSTERONE ASSAY | CDZ | Substantially Equivalent | |
| K023891 | ST AIA-PACK CA 125 ENZYME IMMUNOASSAY | LTK | Substantially Equivalent | |
| K020489 | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE | JPD | Substantially Equivalent | |
| K012820 | AIA-PACK CTNI 2ND-GEN ASSAY | MMI | Substantially Equivalent | |
| K011434 | G7 AUTOMATED HPLC ANALYZER | LCP | Substantially Equivalent | |
| K010796 | AIA-PACK BRCA, ST AIA PACK BRCA | MOI | Substantially Equivalent | |
| K992365 | AIA-PACK FOLATE ASSAY | CGN | Substantially Equivalent | |
| K990431 | AIA-PACK CA 125 | LTK | Substantially Equivalent | |
| K991252 | AIA-PACK FT3 ASSAY | CDP | Substantially Equivalent | |
| K984359 | AIA-PACK TROPONIN I ASSAY | MMI | Substantially Equivalent | |
| K981522 | AIA-PACK TGAB ASSAY | JZO | Substantially Equivalent | |
| K981521 | AIA-PACK TPOAB ASSAY | JZO | Substantially Equivalent | |
| K981012 | AIA-PACK MYOGLOBIN ASSAY | DDR | Substantially Equivalent | |
| K972697 | AIA-PACK IGE II ASSAY | DGC | Substantially Equivalent | |
| K972265 | A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER | LCP | Substantially Equivalent | |
| K972586 | AIA-PACK TSH 3RD-GEN ASSAY | JLW | Substantially Equivalent | |
| K971103 | AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM | KHO | Substantially Equivalent | |
| K964348 | AIA-PACK B12 ASSAY | CDD | Substantially Equivalent | |
| K964349 | AIA-PACK FOLATE ASSAY | CGN | Substantially Equivalent | |
| K963687 | AIA-PACK FT3 ASSAY | CDP | Substantially Equivalent | |
| K951848 | AIA-PACK CPR ASSAY | JKD | Substantially Equivalent | |
| K954591 | AIA-PACK CORT ASSAY | JFT | Substantially Equivalent | |
| K936229 | AIA-PACK TT3 ASSAY | CDP | Substantially Equivalent | |
| K932084 | AIA-PACK E2 ASSAY | CHP | Substantially Equivalent | |
| K933269 | AIA-PACK(R) PROG ASSAY | JLS | Substantially Equivalent | |
| K932178 | AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES | JJX | Substantially Equivalent | |
| K924859 | AIA-PACK IGE CALIBRATION VERIFICATION TEST SET | JJX | Substantially Equivalent | |
| K924857 | AIA-PACK CEA CALIBRATION VERIFICATION TEST SET | DHX | Substantially Equivalent | |
| K924860 | AIA-PACK AFP CALIBRATION VERIFICATION TEST SET | JJX | Substantially Equivalent | |
| K924856 | AIA-PACK PRL CALIBRATION VERIFICATION TEST SET | JJX | Substantially Equivalent | |
| K924852 | ASIA-PACK TSH CALIBRATION VERIFICATION TEST SET | JJX | Substantially Equivalent | |
| K924862 | AIA-PACK HCG CALIBRATION VERIFICATION TEST SET | JJX | Substantially Equivalent | |
| K924853 | AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET | JJX | Substantially Equivalent | |
| K924858 | AIA-PACK FER CALIBRATION VERIFICATION TEST SET | DBF | Substantially Equivalent | |
| K924863 | AIA-PACK FSH CALIBRATION VERIFICATION TEST SET | JJX | Substantially Equivalent | |
| K924855 | AIA-PACK T-U CALIBRATION VERIFICATION TEST SET | JJX | Substantially Equivalent | |
| K924854 | AIA-PACK PAP CALIBRATION VERIFICATION TEST SET | JJX | Substantially Equivalent | |
| K905757 | AIA-PACK HGH | CFL | Substantially Equivalent | |
| K900440 | AIA-PACK BMG | JZG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CGNAcid, Folic, Radioimmunoassay
- LCPAssay, Glycosylated Hemoglobin
- DBFFerritin, Antigen, Antiserum, Control
- KHOFluorometer, For Clinical Use
- JFTFluorometric, Cortisol
- JPDHemoglobin A2 Quantitation
- DGCIge, Antigen, Antiserum, Control
- MMIImmunoassay Method, Troponin Subunit
- LOJKit, Test,Alpha-Fetoprotein For Testicular Cancer
- DDRMyoglobin, Antigen, Antiserum, Control
- CDDRadioassay, Vitamin B12
- JKDRadioimmunoassay, C-Peptides Of Proinsulin
- CHPRadioimmunoassay, Estradiol
- CFLRadioimmunoassay, Human Growth Hormone
- JLSRadioimmunoassay, Progesterone
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDPRadioimmunoassay, Total Triiodothyronine
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- DHXSystem, Test, Carcinoembryonic Antigen
- MOISystem, Test, Immunological, Antigen, Tumor
- JZOSystem, Test, Thyroid Autoantibody
- LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain