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FDA 510(k)

ANTIHUMAN IGG GLOBULIN FITC LABELED

K-Number: K821018 · 1982-04-29

ApplicantMicrobiological Research Corp.
Decision Date1982-04-29
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTIHUMAN IGG GLOBULIN FITC LABELED is the device name listed in this FDA 510(k) record. The listed applicant is Microbiological Research Corp.. It received FDA 510(k) clearance on 1982-04-29 under 510(k) number K821018. 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 ANTIHUMAN IGG GLOBULIN FITC LABELED?

ANTIHUMAN IGG GLOBULIN FITC LABELED is a medical device that received FDA 510(k) clearance on 1982-04-29. The listed applicant is Microbiological Research Corp.. The 510(k) number is K821018.

When did ANTIHUMAN IGG GLOBULIN FITC LABELED receive FDA 510(k) clearance?

ANTIHUMAN IGG GLOBULIN FITC LABELED received FDA 510(k) clearance on 1982-04-29, under 510(k) number K821018.

Who is the listed applicant for ANTIHUMAN IGG GLOBULIN FITC LABELED?

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

What is the FDA product code for ANTIHUMAN IGG GLOBULIN FITC LABELED?

The FDA product code for ANTIHUMAN IGG GLOBULIN FITC LABELED is DEW.

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Other records listing Microbiological Research Corp. as applicant

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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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