Sakura Finetek USA Inc
Torrance, CA, US
SAKURA FINETEK U.S.A., INC. appears in FDA device records in Torrance, CA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Sakura Finetek USA Inc between 1988 and 1989. The busiest year on record is 1988, with 3. The most recent is 1989, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 3 |
| 1989 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K893811 | SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM | JQW | Substantially Equivalent | |
| K882881 | SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER | KES | Substantially Equivalent | |
| K881165 | SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR | IEO | Substantially Equivalent | |
| K874897 | SAKURA DRS-60 AUTOMATIC SLIDE STAINER | KPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2083544 | 2083544 | SAKURA FINETEK U.S.A., INC. | 1750 W 214th St, TORRANCE, CA 90501 US | 2026 | and 20 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KXGApplicator, Absorbent Tipped, Sterile
- GESBlade, Scalpel
- IDZCassettes, Tissue
- KERContainer, Embedding
- NNKContainer, Specimen Mailer And Storage, Non-Sterile
- KESCoverslips, Microscope Slide
- IFBCytocentrifuge
- KIMDevice For Sealing Microsections
- MXTDevice, Accessory, Cooling Plate For Tissue Embedding Station
- IDWDispensers, Paraffin
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- LDZFixative, Alcohol Containing
- IFPFormalin, Neutral Buffered
- KEOFormulations, Paraffin, All
- PPMGeneral Purpose Reagent
- GDZHandle, Scalpel
- NJTImmunohistochemistry Reagents And Kits
- MDMInstrument, Manual, Surgical, General Use
- IBJLight, Microscope
- KEQMedia, Mounting, Water Soluble
- IDPMicrotome, Cryostat
- IDOMicrotome, Rotary
- LEBMounting Media
- IEOProcessor, Tissue, Automated
- HZTReagent, Schiff
- MVUReagents, Specific, Analyte
- JOKScissors, Medical, Disposable
- KPASlide Stainer, Automated
- KIOSlide Stainer, Immersion Type
- KEWSlides, Microscope
- JQWStation, Pipetting And Diluting, For Clinical Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1748-2014 | Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc. | This Lot has variations in melting temperature. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain