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FDA 510(k)

AUTO CREATININE REAGENT (ABBOTT SYSTEM)

K-Number: K761279 · 1977-02-11

ApplicantHarleco
Decision Date1977-02-11
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTO CREATININE REAGENT (ABBOTT SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1977-02-11 under 510(k) number K761279. 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 AUTO CREATININE REAGENT (ABBOTT SYSTEM)?

AUTO CREATININE REAGENT (ABBOTT SYSTEM) is a medical device that received FDA 510(k) clearance on 1977-02-11. The listed applicant is Harleco. The 510(k) number is K761279.

When did AUTO CREATININE REAGENT (ABBOTT SYSTEM) receive FDA 510(k) clearance?

AUTO CREATININE REAGENT (ABBOTT SYSTEM) received FDA 510(k) clearance on 1977-02-11, under 510(k) number K761279.

Who is the listed applicant for AUTO CREATININE REAGENT (ABBOTT SYSTEM)?

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 AUTO CREATININE REAGENT (ABBOTT SYSTEM)?

The FDA product code for AUTO CREATININE REAGENT (ABBOTT SYSTEM) is CGX.

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Other records listing Harleco as applicant

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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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