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FDA 510(k)

GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC

K-Number: K802257 · 1980-10-31

ApplicantProtos Laboratories
Decision Date1980-10-31
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC is the device name listed in this FDA 510(k) record. The listed applicant is Protos Laboratories. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K802257. 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 GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC?

GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Protos Laboratories. The 510(k) number is K802257.

When did GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC receive FDA 510(k) clearance?

GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802257.

Who is the listed applicant for GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC?

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

What is the FDA product code for GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC?

The FDA product code for GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC is DEW.

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Other records listing Protos Laboratories 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.

K802177GOAT ANTI-HUMAN IGMK802196GOAT ANTI-HUMAN COMPLEMENT C4K791560GOAT ANTI-HUMAN C-REACTIVE PROTEINK791605GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSINK791115GOAR ANTI-HUMAN LAMBODA CHAIN

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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