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FDA 510(k)

IMMUNOGLOBULIN G & G SUBCLASSES

K-Number: K875356 · 1988-02-10

ApplicantBirmingham
Decision Date1988-02-10
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOGLOBULIN G & G SUBCLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Birmingham. It received FDA 510(k) clearance on 1988-02-10 under 510(k) number K875356. 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 IMMUNOGLOBULIN G & G SUBCLASSES?

IMMUNOGLOBULIN G & G SUBCLASSES is a medical device that received FDA 510(k) clearance on 1988-02-10. The listed applicant is Birmingham. The 510(k) number is K875356.

When did IMMUNOGLOBULIN G & G SUBCLASSES receive FDA 510(k) clearance?

IMMUNOGLOBULIN G & G SUBCLASSES received FDA 510(k) clearance on 1988-02-10, under 510(k) number K875356.

Who is the listed applicant for IMMUNOGLOBULIN G & G SUBCLASSES?

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

What is the FDA product code for IMMUNOGLOBULIN G & G SUBCLASSES?

The FDA product code for IMMUNOGLOBULIN G & G SUBCLASSES 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

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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