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FDA 510(k)

GONORRHEA TRANSETTE 3

K-Number: K822886 · 1982-10-27

ApplicantSpectrum Diagnostic, Inc.
Decision Date1982-10-27
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GONORRHEA TRANSETTE 3 is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Diagnostic, Inc.. It received FDA 510(k) clearance on 1982-10-27 under 510(k) number K822886. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GONORRHEA TRANSETTE 3?

GONORRHEA TRANSETTE 3 is a medical device that received FDA 510(k) clearance on 1982-10-27. The listed applicant is Spectrum Diagnostic, Inc.. The 510(k) number is K822886.

When did GONORRHEA TRANSETTE 3 receive FDA 510(k) clearance?

GONORRHEA TRANSETTE 3 received FDA 510(k) clearance on 1982-10-27, under 510(k) number K822886.

Who is the listed applicant for GONORRHEA TRANSETTE 3?

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

What is the FDA product code for GONORRHEA TRANSETTE 3?

The FDA product code for GONORRHEA TRANSETTE 3 is JSM.

Related Clinical Trials

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.

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Other records listing Spectrum Diagnostic, Inc. 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.

K831579GONORRHEA TRANSETTE 1 & 3K823443HERPES TRANSETTE

Related Devices (Code: JSM)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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