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FDA 510(k)

OT IGG SORBENT

K-Number: K934324 · 1994-04-21

ApplicantOrganon Teknika Corp.
Decision Date1994-04-21
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

OT IGG SORBENT is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1994-04-21 under 510(k) number K934324. 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 OT IGG SORBENT?

OT IGG SORBENT is a medical device that received FDA 510(k) clearance on 1994-04-21. The listed applicant is Organon Teknika Corp.. The 510(k) number is K934324.

When did OT IGG SORBENT receive FDA 510(k) clearance?

OT IGG SORBENT received FDA 510(k) clearance on 1994-04-21, under 510(k) number K934324.

Who is the listed applicant for OT IGG SORBENT?

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

What is the FDA product code for OT IGG SORBENT?

The FDA product code for OT IGG SORBENT is DEW.

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Other records listing Organon Teknika Corp. 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.

K003104BACT/ALERT CSRK000492MDA D-DIMERK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SN

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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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