FDA 510(k)

MicroScan Prompt Inoculation System-D

K-Number: K221493 · 2023-04-05

Decision Date2023-04-05

Product CodeLIE

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

MicroScan Prompt Inoculation System-D is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2023-04-05 under 510(k) number K221493. The device is classified under product code LIE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MicroScan Prompt Inoculation System-D?

MicroScan Prompt Inoculation System-D is a medical device that received FDA 510(k) clearance on 2023-04-05. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K221493.

When did MicroScan Prompt Inoculation System-D receive FDA 510(k) clearance?

MicroScan Prompt Inoculation System-D received FDA 510(k) clearance on 2023-04-05, under 510(k) number K221493.

Who is the listed applicant for MicroScan Prompt Inoculation System-D?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MicroScan Prompt Inoculation System-D?

The FDA product code for MicroScan Prompt Inoculation System-D is LIE.

Other records listing Beckman Coulter, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252169Access BNP II K254059Access anti-HBc IgM K253687Access anti-HBc Total K251995Access anti-HAV IgM K250588Access Rubella IgG PMA P980041KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

View all 84 devices →

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.