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FDA 510(k)

ABBOTT IGE EIA

K-Number: K832360 · 1983-10-14

ApplicantAbbott Laboratories
Decision Date1983-10-14
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ABBOTT IGE EIA is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K832360. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT IGE EIA?

ABBOTT IGE EIA is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Abbott Laboratories. The 510(k) number is K832360.

When did ABBOTT IGE EIA receive FDA 510(k) clearance?

ABBOTT IGE EIA received FDA 510(k) clearance on 1983-10-14, under 510(k) number K832360.

Who is the listed applicant for ABBOTT IGE EIA?

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

What is the FDA product code for ABBOTT IGE EIA?

The FDA product code for ABBOTT IGE EIA is DGC.

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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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