Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026940910

FEI Number

3026940910

Entity Name

SPOT HEALTH INC.

City/State/Country

Cincinnati, OH, US

Establishment Address

1776 Mentor Ave., Cincinnati, OH 45212, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Spot Health Inc. (Owner Number: 10089149)

Owner / Operator Contact Address

1776 Mentor Ave., Cincinnati, OH 45212, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220643

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	Class 2	862.1675	2023-11-09
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-11-09
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2023-11-09
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-11-09
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2023-11-09
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2023-11-09
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2023-11-09
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-11-09
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-11-09

Official Correspondent

Andrew Jajack

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spot Health Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

Similar Registrations

Registration Number	Establishment Name	Location
3019792804	MHC HEALTH MANAGEMENT SOLUTIONS, LLC	Cape Coral, FL, US
3031090645	IXLAYER	San Francisco, CA, US
1061124	Sterigenics U.S., LLC	Charlotte, NC, US
3020139194	LetsGetChecked Inc.	Cucamonga, CA, US
3011854503	BIODESIX, INC.	Louisville, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026940910. Last updated year: 2026. Please use registration number 3026940910 when referencing this establishment in official correspondence.