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FDA 510(k)

SYSTEMATE URICACID TEST, TECHNICON RA 1000

K-Number: K923765 · 1992-09-22

ApplicantEm Diagnostic Systems, Inc.
Decision Date1992-09-22
Product CodeCDO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSTEMATE URICACID TEST, TECHNICON RA 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1992-09-22 under 510(k) number K923765. The device is classified under product code CDO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEMATE URICACID TEST, TECHNICON RA 1000?

SYSTEMATE URICACID TEST, TECHNICON RA 1000 is a medical device that received FDA 510(k) clearance on 1992-09-22. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K923765.

When did SYSTEMATE URICACID TEST, TECHNICON RA 1000 receive FDA 510(k) clearance?

SYSTEMATE URICACID TEST, TECHNICON RA 1000 received FDA 510(k) clearance on 1992-09-22, under 510(k) number K923765.

Who is the listed applicant for SYSTEMATE URICACID TEST, TECHNICON RA 1000?

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

What is the FDA product code for SYSTEMATE URICACID TEST, TECHNICON RA 1000?

The FDA product code for SYSTEMATE URICACID TEST, TECHNICON RA 1000 is CDO.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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Related Devices (Code: CDO)

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.

K033278RANDOX URIC ACIDRandox Laboratories, Ltd.K992798SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100PSigma Diagnostics, Inc.K982251SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KITSigma Diagnostics, Inc.K981766URIC ACIDAbbott LaboratoriesK981189URIC ACIDAbbott LaboratoriesK971485URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, 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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