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FDA 510(k)

ULTRA LOW LEVEL IMMUNOGLOBULIN G

K-Number: K761224 · 1977-04-07

ApplicantIntl. Diagnostic Technology
Decision Date1977-04-07
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ULTRA LOW LEVEL IMMUNOGLOBULIN G is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Diagnostic Technology. It received FDA 510(k) clearance on 1977-04-07 under 510(k) number K761224. 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 ULTRA LOW LEVEL IMMUNOGLOBULIN G?

ULTRA LOW LEVEL IMMUNOGLOBULIN G is a medical device that received FDA 510(k) clearance on 1977-04-07. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K761224.

When did ULTRA LOW LEVEL IMMUNOGLOBULIN G receive FDA 510(k) clearance?

ULTRA LOW LEVEL IMMUNOGLOBULIN G received FDA 510(k) clearance on 1977-04-07, under 510(k) number K761224.

Who is the listed applicant for ULTRA LOW LEVEL IMMUNOGLOBULIN G?

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

What is the FDA product code for ULTRA LOW LEVEL IMMUNOGLOBULIN G?

The FDA product code for ULTRA LOW LEVEL IMMUNOGLOBULIN G is DEW.

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Other records listing Intl. Diagnostic Technology as applicant

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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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