Data / Medical devices / United States / Scientific Supplies & Technology, Inc.
Scientific Supplies & Technology, Inc.: FDA-registered device maker in Doral, FL, United States, 16 510(k) clearances
Scientific Supplies & Technology, Inc. is registered with the FDA (registration 1036362) in Doral, FL, United States. It lists 89 device types. The FDA files 16 510(k) clearances under its listings, the newest dated September 1, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1036362
- Address
- 7245 N.W. 43RD ST., Doral, FL, United States, 33166
- Owner or operator
- SST International Inc. (1036362)
- Roles
- Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer
- First device listed
- June 19, 2018
- Registered through
- 2027
- Brand names listed
- ACT 5 DIFF, ACT 5 DIFF AL, Bio-Chem, Clinitek Analyzer, EON Analyzer, EXCELSIOR AS TISSUE PROCESSOR, Easylyte Analyzer, Envoy Analyzer and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 1, 2016 | K160429 | BC-5390 Auto Hematology Analyzer | GKZ | Substantially Equivalent | Mindray Bio-Medical Electronics Co., Ltd. | accessdata.fda.gov |
| December 15, 2010 | K100060 | EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 | KHS | Substantially Equivalent | Vital Diagnostics (Manufacturing) Ptyltd | accessdata.fda.gov |
| April 6, 2010 | K100673 | EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020 | JGS | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| December 28, 2006 | K063276 | CLINITEK ADVANTUS, MODEL 1420 | JIL | Substantially Equivalent | Bayer Healthcare, LLC | accessdata.fda.gov |
| October 12, 2004 | K042173 | COULTER A T 5DIFF CAP PIERCE (CP) | GKZ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 19, 2003 | K031947 | BAYER CLINITEK STATUS ANALYZER | KQO | Substantially Equivalent | Bayer Healthcare, LLC | accessdata.fda.gov |
| July 24, 2003 | K032013 | COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| August 21, 2002 | K022603 | IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER | CEW | Substantially Equivalent | Diagnostic Products Corp. | accessdata.fda.gov |
| July 25, 2002 | K021504 | TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540 | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| February 9, 2001 | K993856 | TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| November 12, 1997 | K962282 | TUTTNAUER PREVACUUM TABLE AUTOCLAVE | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| October 29, 1997 | K973550 | TUTTNAUER TABLE-TOP AUTOCLAVE | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| April 8, 1997 | K970227 | IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER | JJE | Substantially Equivalent | Dpc Cirrus | accessdata.fda.gov |
| April 20, 1995 | K945271 | ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM | JJE | Substantially Equivalent | Bio-Chem Laboratory Systems, Inc. | accessdata.fda.gov |
| September 29, 1992 | K924084 | ATAC 6000 CHEMISTRY ANALYZER | JJE | Substantially Equivalent | Bio-Chem Laboratory Systems, Inc. | accessdata.fda.gov |
| June 4, 1985 | K850264 | TUTTNAUER PRE-VACUUM AUTOCLAVE | FLE | Substantially Equivalent | Tuttnauer Co. , Ltd. | accessdata.fda.gov |
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Updated September 1, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.