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FDA 510(k)

IGG SUCLASS EIA

K-Number: K921575 · 1992-05-28

ApplicantVirotech Diagnostika
Decision Date1992-05-28
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IGG SUCLASS EIA is the device name listed in this FDA 510(k) record. The listed applicant is Virotech Diagnostika. It received FDA 510(k) clearance on 1992-05-28 under 510(k) number K921575. 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 SUCLASS EIA?

IGG SUCLASS EIA is a medical device that received FDA 510(k) clearance on 1992-05-28. The listed applicant is Virotech Diagnostika. The 510(k) number is K921575.

When did IGG SUCLASS EIA receive FDA 510(k) clearance?

IGG SUCLASS EIA received FDA 510(k) clearance on 1992-05-28, under 510(k) number K921575.

Who is the listed applicant for IGG SUCLASS EIA?

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

What is the FDA product code for IGG SUCLASS EIA?

The FDA product code for IGG SUCLASS EIA is DEW.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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