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FDA 510(k)

UNIPAK BUN

K-Number: K771087 · 1977-07-21

ApplicantHarleco
Decision Date1977-07-21
Product CodeCDW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNIPAK BUN is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1977-07-21 under 510(k) number K771087. The device is classified under product code CDW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIPAK BUN?

UNIPAK BUN is a medical device that received FDA 510(k) clearance on 1977-07-21. The listed applicant is Harleco. The 510(k) number is K771087.

When did UNIPAK BUN receive FDA 510(k) clearance?

UNIPAK BUN received FDA 510(k) clearance on 1977-07-21, under 510(k) number K771087.

Who is the listed applicant for UNIPAK BUN?

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 UNIPAK BUN?

The FDA product code for UNIPAK BUN is CDW.

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Related Devices (Code: CDW)

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.

K874532BLOOD UREA NITROGENCatachem, Inc.K871320FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814American Research Products Co.K863425AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346American Research Products Co.K861775TWIN BUN/GLUCOSEBoehringer Mannheim Corp.K860419UREA NITROGEN REAGENT SETSterling Diagnostics, Inc.K850937UREADilab, Inc.

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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