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FDA 510(k)

ANTI-HUMAN IGG SERUM

K-Number: K791281 · 1979-11-27

ApplicantDiagnostica, Inc.
Decision Date1979-11-27
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-HUMAN IGG SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica, Inc.. It received FDA 510(k) clearance on 1979-11-27 under 510(k) number K791281. 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 ANTI-HUMAN IGG SERUM?

ANTI-HUMAN IGG SERUM is a medical device that received FDA 510(k) clearance on 1979-11-27. The listed applicant is Diagnostica, Inc.. The 510(k) number is K791281.

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

ANTI-HUMAN IGG SERUM received FDA 510(k) clearance on 1979-11-27, under 510(k) number K791281.

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

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

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

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

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Other records listing Diagnostica, 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.

K002756EASE-A-CULTK823348H. INFLUENZA B ANTISERA FOR CIEK812434DIAGNOSTIC KITS & KIT COMPONENTSK800398PARACONTROL ABNORMAL IMMUNOGLOBULIN CONTK791284ANTI-HUMAN KAPPA SERUMK791283ANTI-HUMAN LAMBDA SERUM

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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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