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FDA 510(k)

TOXOPLASMA GONDII IGG ELISA

K-Number: K871905 · 1987-07-30

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1987-07-30
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXOPLASMA GONDII IGG ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics Laboratories, Inc.. It received FDA 510(k) clearance on 1987-07-30 under 510(k) number K871905. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOXOPLASMA GONDII IGG ELISA?

TOXOPLASMA GONDII IGG ELISA is a medical device that received FDA 510(k) clearance on 1987-07-30. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K871905.

When did TOXOPLASMA GONDII IGG ELISA receive FDA 510(k) clearance?

TOXOPLASMA GONDII IGG ELISA received FDA 510(k) clearance on 1987-07-30, under 510(k) number K871905.

Who is the listed applicant for TOXOPLASMA GONDII IGG ELISA?

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

What is the FDA product code for TOXOPLASMA GONDII IGG ELISA?

The FDA product code for TOXOPLASMA GONDII IGG ELISA is LGD.

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Other records listing Electro-Nucleonics Laboratories, Inc. as applicant

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Related Devices (Code: LGD)

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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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