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FDA 510(k)

IGG IMMUNOTURBIDIMETRIC & CALIBRATOR

K-Number: K955798 · 1996-04-05

ApplicantRandox Laboratories, Ltd.
Decision Date1996-04-05
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IGG IMMUNOTURBIDIMETRIC & CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 1996-04-05 under 510(k) number K955798. 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 IGG IMMUNOTURBIDIMETRIC & CALIBRATOR?

IGG IMMUNOTURBIDIMETRIC & CALIBRATOR is a medical device that received FDA 510(k) clearance on 1996-04-05. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K955798.

When did IGG IMMUNOTURBIDIMETRIC & CALIBRATOR receive FDA 510(k) clearance?

IGG IMMUNOTURBIDIMETRIC & CALIBRATOR received FDA 510(k) clearance on 1996-04-05, under 510(k) number K955798.

Who is the listed applicant for IGG IMMUNOTURBIDIMETRIC & CALIBRATOR?

The FDA 510(k) record lists Randox Laboratories, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IGG IMMUNOTURBIDIMETRIC & CALIBRATOR?

The FDA product code for IGG IMMUNOTURBIDIMETRIC & CALIBRATOR is DEW.

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Other records listing Randox Laboratories, Ltd. 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.

K230890ISE ElectrodesK182042Randox Calcium (Ca)K162200Randox RX Daytona Plus Magnesium (MG)K152085Liquid CO2-2 (LCO2-2)K153435Direct HDL Cholesterol (HDL)K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

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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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