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FDA 510(k)

MICRODOSE RC-EZ

K-Number: K924825 · 1993-03-05

ApplicantUnicep
Decision Date1993-03-05
Product CodeEKM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MICRODOSE RC-EZ is the device name listed in this FDA 510(k) record. The listed applicant is Unicep. It received FDA 510(k) clearance on 1993-03-05 under 510(k) number K924825. The device is classified under product code EKM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRODOSE RC-EZ?

MICRODOSE RC-EZ is a medical device that received FDA 510(k) clearance on 1993-03-05. The listed applicant is Unicep. The 510(k) number is K924825.

When did MICRODOSE RC-EZ receive FDA 510(k) clearance?

MICRODOSE RC-EZ received FDA 510(k) clearance on 1993-03-05, under 510(k) number K924825.

Who is the listed applicant for MICRODOSE RC-EZ?

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

What is the FDA product code for MICRODOSE RC-EZ?

The FDA product code for MICRODOSE RC-EZ is EKM.

Related Clinical Trials

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.

Other records listing Unicep 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.

View all 9 devices →

Related Devices (Code: EKM)

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.

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.

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