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FDA 510(k)

GONOCHEK-II, MODIFICATION

K-Number: K934125 · 1994-09-09

ApplicantE-Y Laboratories, Inc.
Decision Date1994-09-09
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GONOCHEK-II, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is E-Y Laboratories, Inc.. It received FDA 510(k) clearance on 1994-09-09 under 510(k) number K934125. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GONOCHEK-II, MODIFICATION?

GONOCHEK-II, MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-09-09. The listed applicant is E-Y Laboratories, Inc.. The 510(k) number is K934125.

When did GONOCHEK-II, MODIFICATION receive FDA 510(k) clearance?

GONOCHEK-II, MODIFICATION received FDA 510(k) clearance on 1994-09-09, under 510(k) number K934125.

Who is the listed applicant for GONOCHEK-II, MODIFICATION?

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

What is the FDA product code for GONOCHEK-II, MODIFICATION?

The FDA product code for GONOCHEK-II, MODIFICATION is JTO.

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Other records listing E-Y Laboratories, 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.

K934130SWABZYME OXIDASEK940162GONOCHEK II REAGENT TUBESK940161B-LACTAMASE REAGENT TUBESK940124EY-20 REAGENT TUBESK934129STREP-A-CHEKK940020STREP-A-CHEK(TM) REAGENT STRIPS

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Related Devices (Code: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, Inc.

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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