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FDA 510(k)

EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.

K-Number: K821963 · 1982-07-27

ApplicantIntl. Immunoassay Laboratories, Inc.
Decision Date1982-07-27
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT. is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Immunoassay Laboratories, Inc.. It received FDA 510(k) clearance on 1982-07-27 under 510(k) number K821963. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.?

EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT. is a medical device that received FDA 510(k) clearance on 1982-07-27. The listed applicant is Intl. Immunoassay Laboratories, Inc.. The 510(k) number is K821963.

When did EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT. receive FDA 510(k) clearance?

EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT. received FDA 510(k) clearance on 1982-07-27, under 510(k) number K821963.

Who is the listed applicant for EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.?

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

What is the FDA product code for EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.?

The FDA product code for EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT. is GGP.

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Related Devices (Code: GGP)

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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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