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The Monarch Company, LLC

Birmingham, AL, US

THE MONARCH COMPANY, LLC appears in FDA device records in Birmingham, AL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for The Monarch Company, LLC in 2023.

Clearances by year, as a table
510(k) clearance decisions for The Monarch Company, LLC, by decision year
YearClearances
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232308Monarch Blood Collection SetJKASubstantially Equivalent

Registered establishments

FDA registered establishments for The Monarch Company, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30302439193030243919THE MONARCH COMPANY, LLC2700 Corporate Dr Ste 200, Birmingham, AL 35242 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain