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FDA 510(k)

ALLERGENETICS ALLER-SPECIFIC IGE SERUM

K-Number: K842969 · 1984-08-28

ApplicantAllergenetics
Decision Date1984-08-28
Product CodeDGP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALLERGENETICS ALLER-SPECIFIC IGE SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Allergenetics. It received FDA 510(k) clearance on 1984-08-28 under 510(k) number K842969. The device is classified under product code DGP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLERGENETICS ALLER-SPECIFIC IGE SERUM?

ALLERGENETICS ALLER-SPECIFIC IGE SERUM is a medical device that received FDA 510(k) clearance on 1984-08-28. The listed applicant is Allergenetics. The 510(k) number is K842969.

When did ALLERGENETICS ALLER-SPECIFIC IGE SERUM receive FDA 510(k) clearance?

ALLERGENETICS ALLER-SPECIFIC IGE SERUM received FDA 510(k) clearance on 1984-08-28, under 510(k) number K842969.

Who is the listed applicant for ALLERGENETICS ALLER-SPECIFIC IGE SERUM?

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

What is the FDA product code for ALLERGENETICS ALLER-SPECIFIC IGE SERUM?

The FDA product code for ALLERGENETICS ALLER-SPECIFIC IGE SERUM is DGP.

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Other records listing Allergenetics 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.

K851512ALLERGENETICS IGE FAST TESTK842970ALLERGENTICS TOTAL IGE/THEOPHYLLINEK833418CHYMOFAST TESTK834594TOTAL IGE FAST TESTK833419LABELED 125I ANTI-IGEK834244THEOFAST TEST KIT FOR QUANTITATIVE THEO

View all 8 devices →

Related Devices (Code: DGP)

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.

K931224VIDAS TOTAL IGE (IGE) ASSAYBiomerieux Vitek, Inc.K863327IMMPULSE IGE ASSAY REAGENTSSclavo, Inc.K842749FIAX TOTAL IGE TEST KITIntl. Diagnostic Technology

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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