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FDA 510(k)

EASY-TEST URIC ACID (URIC) #16606

K-Number: K870868 · 1987-03-19

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-03-19
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASY-TEST URIC ACID (URIC) #16606 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 1987-03-19 under 510(k) number K870868. The device is classified under product code KNK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASY-TEST URIC ACID (URIC) #16606?

EASY-TEST URIC ACID (URIC) #16606 is a medical device that received FDA 510(k) clearance on 1987-03-19. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K870868.

When did EASY-TEST URIC ACID (URIC) #16606 receive FDA 510(k) clearance?

EASY-TEST URIC ACID (URIC) #16606 received FDA 510(k) clearance on 1987-03-19, under 510(k) number K870868.

Who is the listed applicant for EASY-TEST URIC ACID (URIC) #16606?

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 EASY-TEST URIC ACID (URIC) #16606?

The FDA product code for EASY-TEST URIC ACID (URIC) #16606 is KNK.

Other records listing Em Diagnostic Systems, 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.

K935181ASPARTATE AMINOTRANSFERASE (AST) TESTK935180ALANINE AMINOTRANSFERASE (ALT) TESTK935178EMDS PHOSPHOROUS (PHOS) TESTK935179EMDS ALBUMIN (ALB) TESTK935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)

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Related Devices (Code: KNK)

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.

K102568URIC ACID MODEL 3P39Abbott LaboratoriesK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98Olympus America, Inc.K040467VITALAB URIC ACID REAGENTClinical Data, Inc.K031044ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATORClinical Data, Inc.K022096URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.K023550WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDAWiener Laboratories Saic

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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