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FDA 510(k)

SERIM PYLORITEK REAGENT STRIPS

K-Number: K936034 · 1994-04-21

ApplicantSerim Research Corp.
Decision Date1994-04-21
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERIM PYLORITEK REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Serim Research Corp.. It received FDA 510(k) clearance on 1994-04-21 under 510(k) number K936034. 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 SERIM PYLORITEK REAGENT STRIPS?

SERIM PYLORITEK REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1994-04-21. The listed applicant is Serim Research Corp.. The 510(k) number is K936034.

When did SERIM PYLORITEK REAGENT STRIPS receive FDA 510(k) clearance?

SERIM PYLORITEK REAGENT STRIPS received FDA 510(k) clearance on 1994-04-21, under 510(k) number K936034.

Who is the listed applicant for SERIM PYLORITEK REAGENT STRIPS?

The FDA 510(k) record lists Serim Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERIM PYLORITEK REAGENT STRIPS?

The FDA product code for SERIM PYLORITEK REAGENT STRIPS is JTO.

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Other records listing Serim Research Corp. as applicant

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Related Devices (Code: JTO)

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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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