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FDA 510(k)

GONORRHEA TRANSETTE 1 & 3

K-Number: K831579 · 1983-06-17

ApplicantSpectrum Diagnostic, Inc.
Decision Date1983-06-17
Product CodeJTW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GONORRHEA TRANSETTE 1 & 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 1983-06-17 under 510(k) number K831579. The device is classified under product code JTW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GONORRHEA TRANSETTE 1 & 3?

GONORRHEA TRANSETTE 1 & 3 is a medical device that received FDA 510(k) clearance on 1983-06-17. The listed applicant is Spectrum Diagnostic, Inc.. The 510(k) number is K831579.

When did GONORRHEA TRANSETTE 1 & 3 receive FDA 510(k) clearance?

GONORRHEA TRANSETTE 1 & 3 received FDA 510(k) clearance on 1983-06-17, under 510(k) number K831579.

Who is the listed applicant for GONORRHEA TRANSETTE 1 & 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 1 & 3?

The FDA product code for GONORRHEA TRANSETTE 1 & 3 is JTW.

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.

K823443HERPES TRANSETTEK822886GONORRHEA TRANSETTE 3

Related Devices (Code: JTW)

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.

K121039COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEMCopan Flock TechnologiesK061301COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEMCopan Diagnostics, Inc.K022874GEN-PROBE APTIMA COMBO 2 ASSAYGen-Probe, Inc.K013819URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEMSierra Diagnostic, LLCK993161COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMCopan Diagnostics, Inc.K983244SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)Trek Diagnostic Systems, Inc.

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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