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FDA 510(k)

CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED

K-Number: K910147 · 1991-03-11

ApplicantOlympus Corp.
Decision Date1991-03-11
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1991-03-11 under 510(k) number K910147. 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 CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED?

CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED is a medical device that received FDA 510(k) clearance on 1991-03-11. The listed applicant is Olympus Corp.. The 510(k) number is K910147.

When did CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED receive FDA 510(k) clearance?

CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED received FDA 510(k) clearance on 1991-03-11, under 510(k) number K910147.

Who is the listed applicant for CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED?

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

What is the FDA product code for CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED?

The FDA product code for CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED is CGX.

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Other records listing Olympus 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.

K915402EW-10 AND EW-20K933200OLYMPUS PBD STENTSK942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESK931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSK934835FLOVALK931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES

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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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