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FDA 510(k)

ULTRACHEM BUN-UV, 65080 & 65081

K-Number: K822323 · 1982-09-02

ApplicantHarleco Diagnostics
Decision Date1982-09-02
Product CodeCDW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRACHEM BUN-UV, 65080 & 65081 is the device name listed in this FDA 510(k) record. The listed applicant is Harleco Diagnostics. It received FDA 510(k) clearance on 1982-09-02 under 510(k) number K822323. 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 ULTRACHEM BUN-UV, 65080 & 65081?

ULTRACHEM BUN-UV, 65080 & 65081 is a medical device that received FDA 510(k) clearance on 1982-09-02. The listed applicant is Harleco Diagnostics. The 510(k) number is K822323.

When did ULTRACHEM BUN-UV, 65080 & 65081 receive FDA 510(k) clearance?

ULTRACHEM BUN-UV, 65080 & 65081 received FDA 510(k) clearance on 1982-09-02, under 510(k) number K822323.

Who is the listed applicant for ULTRACHEM BUN-UV, 65080 & 65081?

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

What is the FDA product code for ULTRACHEM BUN-UV, 65080 & 65081?

The FDA product code for ULTRACHEM BUN-UV, 65080 & 65081 is CDW.

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Other records listing Harleco Diagnostics 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.

K823147URIC ACID STANDARD, 8MG/DL #65078K822852TRIGLYCERIDE CALIBRATORK821877ULTRAZYME PLUS HBDK821879ULTRACHEM T.P.K821880ULTRA CHEM ALBK821872ULTRACHEM URIC ACID AIDH

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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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