Acetaminophen
K-Number: K202644 · 2022-02-18
ApplicantSekisui Diagnostics P.E.I., Inc.
Decision Date2022-02-18
Product CodeLDP
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
Acetaminophen is a medical device manufactured by Sekisui Diagnostics P.E.I., Inc.. It received FDA 510(k) clearance on 2022-02-18 under approval number K202644. The device is classified under product code LDP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Acetaminophen?
Acetaminophen is a medical device that received FDA 510(k) clearance on 2022-02-18. It is manufactured by Sekisui Diagnostics P.E.I., Inc.. The 510(k) number is K202644.
When was Acetaminophen approved by the FDA?
Acetaminophen received FDA 510(k) clearance on 2022-02-18, under approval number K202644.
What company makes Acetaminophen?
Acetaminophen is manufactured by Sekisui Diagnostics P.E.I., Inc..
What is the FDA product code for Acetaminophen?
The FDA product code for Acetaminophen is LDP.
Other Devices by Sekisui Diagnostics P.E.I., Inc.
Related Devices (Code: LDP)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.