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FDA 510(k)

TIA-IGG REAGENT & CALIBRATOR SETS

K-Number: K831101 · 1983-04-27

ApplicantWorthington Diagnostic Systems
Decision Date1983-04-27
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TIA-IGG REAGENT & CALIBRATOR SETS is the device name listed in this FDA 510(k) record. The listed applicant is Worthington Diagnostic Systems. It received FDA 510(k) clearance on 1983-04-27 under 510(k) number K831101. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIA-IGG REAGENT & CALIBRATOR SETS?

TIA-IGG REAGENT & CALIBRATOR SETS is a medical device that received FDA 510(k) clearance on 1983-04-27. The listed applicant is Worthington Diagnostic Systems. The 510(k) number is K831101.

When did TIA-IGG REAGENT & CALIBRATOR SETS receive FDA 510(k) clearance?

TIA-IGG REAGENT & CALIBRATOR SETS received FDA 510(k) clearance on 1983-04-27, under 510(k) number K831101.

Who is the listed applicant for TIA-IGG REAGENT & CALIBRATOR SETS?

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

What is the FDA product code for TIA-IGG REAGENT & CALIBRATOR SETS?

The FDA product code for TIA-IGG REAGENT & CALIBRATOR SETS is DEW.

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Other records listing Worthington Diagnostic Systems 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.

K833708COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTEK832749EASYTOUCH BUN REAGENT SETK832427EASYTOUCH TROMBOPLASTIN REAGENTK832748COMPUR* EASYTOUCH TOTAL BILIRUBINK832785COMPUR* EASY TOUCH URIC ACID REAGENTK832750EASYTOUCH HEMOGLOBIN REAGENT

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Related Devices (Code: DEW)

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.

K050113TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K010617SPIFE IFE CALIBRATOR AND CONTROL KITHelena LaboratoriesK993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWako Chemicals USA, Inc.K993281K-ASSAY IGGKamiya Biomedical Co.K983221IGGAbbott Laboratories

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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