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FDA 510(k)

SERUM, IGG GOAT ANTI-HUMAN ACID

K-Number: K760145 · 1976-07-19

ApplicantOxford Laboratories, Inc.
Decision Date1976-07-19
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SERUM, IGG GOAT ANTI-HUMAN ACID is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Laboratories, Inc.. It received FDA 510(k) clearance on 1976-07-19 under 510(k) number K760145. 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 SERUM, IGG GOAT ANTI-HUMAN ACID?

SERUM, IGG GOAT ANTI-HUMAN ACID is a medical device that received FDA 510(k) clearance on 1976-07-19. The listed applicant is Oxford Laboratories, Inc.. The 510(k) number is K760145.

When did SERUM, IGG GOAT ANTI-HUMAN ACID receive FDA 510(k) clearance?

SERUM, IGG GOAT ANTI-HUMAN ACID received FDA 510(k) clearance on 1976-07-19, under 510(k) number K760145.

Who is the listed applicant for SERUM, IGG GOAT ANTI-HUMAN ACID?

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

What is the FDA product code for SERUM, IGG GOAT ANTI-HUMAN ACID?

The FDA product code for SERUM, IGG GOAT ANTI-HUMAN ACID is DEW.

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Other records listing Oxford 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.

K780912ADJUSTABLE DISPENSORK760144SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACIDK760148SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMANK760078REAGENT, RIA TRIIODOTHYRONINE T3 (#200)K760079REAGENT, THYROXINE T4 (#210)K760146SERUM, IGA GOAT ANTI-HUMAN ACID

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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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