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FDA 510(k)

WORTHINGTON BUN

K-Number: K770470 · 1977-06-02

ApplicantWorthington Biochemical Corp.
Decision Date1977-06-02
Product CodeCDW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WORTHINGTON BUN is the device name listed in this FDA 510(k) record. The listed applicant is Worthington Biochemical Corp.. It received FDA 510(k) clearance on 1977-06-02 under 510(k) number K770470. 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 WORTHINGTON BUN?

WORTHINGTON BUN is a medical device that received FDA 510(k) clearance on 1977-06-02. The listed applicant is Worthington Biochemical Corp.. The 510(k) number is K770470.

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

WORTHINGTON BUN received FDA 510(k) clearance on 1977-06-02, under 510(k) number K770470.

Who is the listed applicant for WORTHINGTON BUN?

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

What is the FDA product code for WORTHINGTON BUN?

The FDA product code for WORTHINGTON BUN is CDW.

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Other records listing Worthington Biochemical Corp. 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.

K780389HDL REAGENT SET FOR LIPOPROTEINSK780096LDH ISOENZYME CONTROL SERUMK772356LDH ISOENZYME COLUMN REAGENT SETK772025URIC ACID STD. FOR QUANT. URIC ACIDK771143INORGANIC PHOSPHORUS STANDARDSK770831STATZYME URIC ACID REAGENT

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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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