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FDA 510(k)

JAMES REAGENT

K-Number: K890625 · 1989-02-17

ApplicantDms Products, Inc.
Decision Date1989-02-17
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

JAMES REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Dms Products, Inc.. It received FDA 510(k) clearance on 1989-02-17 under 510(k) number K890625. 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 JAMES REAGENT?

JAMES REAGENT is a medical device that received FDA 510(k) clearance on 1989-02-17. The listed applicant is Dms Products, Inc.. The 510(k) number is K890625.

When did JAMES REAGENT receive FDA 510(k) clearance?

JAMES REAGENT received FDA 510(k) clearance on 1989-02-17, under 510(k) number K890625.

Who is the listed applicant for JAMES REAGENT?

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

What is the FDA product code for JAMES REAGENT?

The FDA product code for JAMES REAGENT is JTO.

Related Clinical Trials

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Other records listing Dms Products, 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.

K891004RAPIDEC STAPHK894805RAPIDEC URK890626RAPIDEC COLIK854733API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT)K854732API 50 CHB (CULTURE MEDIA)

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

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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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