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FDA 510(k)

ANTIBODY TO CHLAMYDIA TRACHOMATIS

K-Number: K811570 · 1981-07-23

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1981-07-23
Product CodeGPW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ANTIBODY TO CHLAMYDIA TRACHOMATIS 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 1981-07-23 under 510(k) number K811570. The device is classified under product code GPW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTIBODY TO CHLAMYDIA TRACHOMATIS?

ANTIBODY TO CHLAMYDIA TRACHOMATIS is a medical device that received FDA 510(k) clearance on 1981-07-23. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K811570.

When did ANTIBODY TO CHLAMYDIA TRACHOMATIS receive FDA 510(k) clearance?

ANTIBODY TO CHLAMYDIA TRACHOMATIS received FDA 510(k) clearance on 1981-07-23, under 510(k) number K811570.

Who is the listed applicant for ANTIBODY TO CHLAMYDIA TRACHOMATIS?

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 ANTIBODY TO CHLAMYDIA TRACHOMATIS?

The FDA product code for ANTIBODY TO CHLAMYDIA TRACHOMATIS is GPW.

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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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