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FDA 510(k)

CREATININE

K-Number: K880629 · 1988-03-23

ApplicantTech-Co, Inc.
Decision Date1988-03-23
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Co, Inc.. It received FDA 510(k) clearance on 1988-03-23 under 510(k) number K880629. 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?

CREATININE is a medical device that received FDA 510(k) clearance on 1988-03-23. The listed applicant is Tech-Co, Inc.. The 510(k) number is K880629.

When did CREATININE receive FDA 510(k) clearance?

CREATININE received FDA 510(k) clearance on 1988-03-23, under 510(k) number K880629.

Who is the listed applicant for CREATININE?

The FDA 510(k) record lists Tech-Co, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREATININE?

The FDA product code for CREATININE is CGX.

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Other records listing Tech-Co, Inc. 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.

K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTK923376VISUAL HCG PREGNANCY TESTK920766T4 EIA BEAD ASSAYK920716DIRECT PREGNANCY TESTK902574POTASSIUM REAGENT SETK901561IRON/TOTAL IRON BINDING CAPACITY

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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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