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FDA 510(k)

GULLSORB IGG INACTIVATION REAGENT

K-Number: K875254 · 1988-02-17

ApplicantGull Laboratories, Inc.
Decision Date1988-02-17
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GULLSORB IGG INACTIVATION REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Gull Laboratories, Inc.. It received FDA 510(k) clearance on 1988-02-17 under 510(k) number K875254. 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 GULLSORB IGG INACTIVATION REAGENT?

GULLSORB IGG INACTIVATION REAGENT is a medical device that received FDA 510(k) clearance on 1988-02-17. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K875254.

When did GULLSORB IGG INACTIVATION REAGENT receive FDA 510(k) clearance?

GULLSORB IGG INACTIVATION REAGENT received FDA 510(k) clearance on 1988-02-17, under 510(k) number K875254.

Who is the listed applicant for GULLSORB IGG INACTIVATION REAGENT?

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

What is the FDA product code for GULLSORB IGG INACTIVATION REAGENT?

The FDA product code for GULLSORB IGG INACTIVATION REAGENT is DEW.

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Other records listing Gull Laboratories, Inc. 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.

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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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