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FDA 510(k)

STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR

K-Number: K880467 · 1988-03-24

ApplicantStanbio Laboratory
Decision Date1988-03-24
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1988-03-24 under 510(k) number K880467. The device is classified under product code JIY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR?

STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR is a medical device that received FDA 510(k) clearance on 1988-03-24. The listed applicant is Stanbio Laboratory. The 510(k) number is K880467.

When did STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR receive FDA 510(k) clearance?

STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR received FDA 510(k) clearance on 1988-03-24, under 510(k) number K880467.

Who is the listed applicant for STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR?

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

What is the FDA product code for STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR?

The FDA product code for STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR is JIY.

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Other records listing Stanbio Laboratory 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.

K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMK081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMK050266DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORK050283CREATININE LIQUICOLORK042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERK041155WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY

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Related Devices (Code: JIY)

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.

K061793DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATORDade Behring, Inc.K060264DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)Dade Behring, Inc.K051115SENTINEL IRON LIQUIDSentinel Ch. SrlK033983VITALAB IRON REAGENTClinical Data, Inc.K030528ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)Clinical DataK020816IRON-PC-SL ASSAY MODEL # 151-10, 151-26Diagnostic Chemicals , Ltd.

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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