Data / Medical devices / United States / Saris And Things, Inc.
Saris And Things, Inc.: FDA-registered device maker in Plainfield, IL, United States, 7 510(k) clearances
Saris And Things, Inc. is registered with the FDA (registration 3017923561) in Plainfield, IL, United States. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 19, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017923561
- Address
- 24119 W Riverwalk Ct. Unit 131, Plainfield, IL, United States, 60544
- Owner or operator
- Saris and Things, Inc. (10080196)
- Roles
- Repackager or relabeler
- First device listed
- November 1, 2023
- Registered through
- 2026
- Brand names listed
- ADX100, BD, Medline, OWEN MUMFORD INC, Polymedco, SNT Biotech, Unistik, Whatman
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Occult Blood Analyzer | OOX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Blood And Urine Collection Kit (Excludes Hiv Testing) | OIB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | 2 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Repackager or relabeler | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| April 19, 2023 | K223201 | TAP Lancet | FMK | Unknown | Yourbio Health, Inc. | accessdata.fda.gov |
| December 16, 2022 | K223243 | BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets | FMK | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| September 7, 2022 | K222111 | Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G | FMK | Substantially Equivalent | Owen Mumford, Ltd. | accessdata.fda.gov |
| August 12, 2022 | K221131 | Tasso+ | FMK | Substantially Equivalent | Tasso, Inc. | accessdata.fda.gov |
| July 8, 2022 | K220643 | DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets | FMK | Substantially Equivalent | Htl-Strefa S.A | accessdata.fda.gov |
| January 8, 2010 | K092330 | OC-SENSOR DIANA IFOB TEST | OOX | Substantially Equivalent | Polymedco Cancer Diagnostics, LLC | accessdata.fda.gov |
| July 28, 1999 | K991702 | MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
Compare with other makers
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Automated Occult Blood Analyzer
- All makers of Blood And Urine Collection Kit (Excludes Hiv Testing)
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Blood Specimen Collection Convenience Kit (Excludes Hiv)
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
Updated April 19, 2023. 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.