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FDA 510(k)

SERUM CREATININE; ALK. BUFFER & PICRIC

K-Number: K800219 · 1980-02-26

ApplicantFisher Scientific Co., LLC
Decision Date1980-02-26
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM CREATININE; ALK. BUFFER & PICRIC is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1980-02-26 under 510(k) number K800219. 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 SERUM CREATININE; ALK. BUFFER & PICRIC?

SERUM CREATININE; ALK. BUFFER & PICRIC is a medical device that received FDA 510(k) clearance on 1980-02-26. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K800219.

When did SERUM CREATININE; ALK. BUFFER & PICRIC receive FDA 510(k) clearance?

SERUM CREATININE; ALK. BUFFER & PICRIC received FDA 510(k) clearance on 1980-02-26, under 510(k) number K800219.

Who is the listed applicant for SERUM CREATININE; ALK. BUFFER & PICRIC?

The FDA 510(k) record lists Fisher Scientific Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERUM CREATININE; ALK. BUFFER & PICRIC?

The FDA product code for SERUM CREATININE; ALK. BUFFER & PICRIC is CGX.

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Other records listing Fisher Scientific Co., LLC 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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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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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