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FDA 510(k)

PYR/ESCULIN DISK

K-Number: K880950 · 1988-04-01

ApplicantRemel Co.
Decision Date1988-04-01
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PYR/ESCULIN DISK is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1988-04-01 under 510(k) number K880950. 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 PYR/ESCULIN DISK?

PYR/ESCULIN DISK is a medical device that received FDA 510(k) clearance on 1988-04-01. The listed applicant is Remel Co.. The 510(k) number is K880950.

When did PYR/ESCULIN DISK receive FDA 510(k) clearance?

PYR/ESCULIN DISK received FDA 510(k) clearance on 1988-04-01, under 510(k) number K880950.

Who is the listed applicant for PYR/ESCULIN DISK?

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

What is the FDA product code for PYR/ESCULIN DISK?

The FDA product code for PYR/ESCULIN DISK is JTO.

Related Clinical Trials

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Other records listing Remel Co. 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.

K013711BACTI-SWAB DRYK965151A.C.T. IIIK965150A.C.T. IVK965152A.C.T. IIK965149A.C.T. IK960090CALCOFLUOR WHITE STAIN KIT

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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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