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FDA 510(k)

ULTRACHEM TP, ITEM #64974

K-Number: K813038 · 1981-11-10

ApplicantHarleco
Decision Date1981-11-10
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRACHEM TP, ITEM #64974 is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1981-11-10 under 510(k) number K813038. The device is classified under product code CEK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACHEM TP, ITEM #64974?

ULTRACHEM TP, ITEM #64974 is a medical device that received FDA 510(k) clearance on 1981-11-10. The listed applicant is Harleco. The 510(k) number is K813038.

When did ULTRACHEM TP, ITEM #64974 receive FDA 510(k) clearance?

ULTRACHEM TP, ITEM #64974 received FDA 510(k) clearance on 1981-11-10, under 510(k) number K813038.

Who is the listed applicant for ULTRACHEM TP, ITEM #64974?

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 TP, ITEM #64974?

The FDA product code for ULTRACHEM TP, ITEM #64974 is CEK.

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Other records listing Harleco 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.

K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DHK813043ULTRACHEM CREA ITEM #64972K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813041ULTRAZYME-GT, ITEM #64959 & 65032K813044ULTRACHEM ALB, ITEM #64970

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Related Devices (Code: CEK)

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.

K992846HICHEM TOTAL PROTEIN REAGENTElan Holdings, Inc.K973108TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50Diagnostic Chemicals , Ltd.K980042CARESIDE TOTAL PROTEINExigent Diagnostics, Inc.K971524TOTAL PROTEIN OR TPCarolina Liquid Chemistries Corp.K961864CSF/URINE TOTAL PROTEINTeco DiagnosticsK955905STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAYSolarcare Technologies Corp,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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