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FDA 510(k)

ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM

K-Number: K780515 · 1978-05-19

ApplicantHarleco
Decision Date1978-05-19
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1978-05-19 under 510(k) number K780515. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM?

ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM is a medical device that received FDA 510(k) clearance on 1978-05-19. The listed applicant is Harleco. The 510(k) number is K780515.

When did ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM receive FDA 510(k) clearance?

ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM received FDA 510(k) clearance on 1978-05-19, under 510(k) number K780515.

Who is the listed applicant for ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM?

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

What is the FDA product code for ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM?

The FDA product code for ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM is CFR.

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Other records listing Harleco as applicant

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Related Devices (Code: CFR)

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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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