Data / Medical devices / United States / Spot Health Inc.
Spot Health Inc.: FDA-registered device maker in Cincinnati, OH, United States, 7 510(k) clearances
Spot Health Inc. is registered with the FDA (registration 3026940910) in Cincinnati, OH, United States. It lists 9 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
- 3026940910
- Address
- 1776 Mentor Ave., Cincinnati, OH, United States, 45212
- Owner or operator
- Spot Health Inc. (10089149)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- November 9, 2023
- Registered through
- 2026
- Brand names listed
- Verisana Urine Sample Collection Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood And Urine Collection Kit (Excludes Hiv Testing) | OIB | 1 | Manufacturer | accessdata.fda.gov |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | 2 | Manufacturer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Manufacturer | accessdata.fda.gov |
| Dna Probe, Nucleic Acid Amplification, Chlamydia | MKZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dna-Reagents, Neisseria | LSL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Real Time Nucleic Acid Amplification System | OOI | 2 | 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 |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | 1 | Manufacturer | 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 |
| March 21, 2018 | K173887 | cobas CT/NG for use on cobas 6800/8800 systems | LSL | Substantially Equivalent | Roche Molecular Systems, Inc. | 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 Container, Specimen Mailer And Storage, Non-Sterile
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Urine Collection Kit (Excludes Hiv Testing)
- All makers of Blood And Urine Collection Kit (Excludes Hiv Testing)
- All makers of Blood Specimen Collection Convenience Kit (Excludes Hiv)
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.