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FDA 510(k)

ULTRACHEM CREA ITEM #64972

K-Number: K813043 · 1981-11-10

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

Device Summary

ULTRACHEM CREA ITEM #64972 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 K813043. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACHEM CREA ITEM #64972?

ULTRACHEM CREA ITEM #64972 is a medical device that received FDA 510(k) clearance on 1981-11-10. The listed applicant is Harleco. The 510(k) number is K813043.

When did ULTRACHEM CREA ITEM #64972 receive FDA 510(k) clearance?

ULTRACHEM CREA ITEM #64972 received FDA 510(k) clearance on 1981-11-10, under 510(k) number K813043.

Who is the listed applicant for ULTRACHEM CREA ITEM #64972?

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 CREA ITEM #64972?

The FDA product code for ULTRACHEM CREA ITEM #64972 is CGX.

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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-DHK813044ULTRACHEM ALB, ITEM #64970K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813038ULTRACHEM TP, ITEM #64974K813041ULTRAZYME-GT, ITEM #64959 & 65032

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Related Devices (Code: CGX)

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.

K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian HealthK242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK210452Creatinine2Abbott Ireland Diagnostics DivisionK161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, 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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