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FDA 510(k)

UREA NITROGEN TEST ITEM NUMBER 65408

K-Number: K932161 · 1993-09-08

ApplicantEm Diagnostic Systems, Inc.
Decision Date1993-09-08
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UREA NITROGEN TEST ITEM NUMBER 65408 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 1993-09-08 under 510(k) number K932161. The device is classified under product code CDQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UREA NITROGEN TEST ITEM NUMBER 65408?

UREA NITROGEN TEST ITEM NUMBER 65408 is a medical device that received FDA 510(k) clearance on 1993-09-08. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K932161.

When did UREA NITROGEN TEST ITEM NUMBER 65408 receive FDA 510(k) clearance?

UREA NITROGEN TEST ITEM NUMBER 65408 received FDA 510(k) clearance on 1993-09-08, under 510(k) number K932161.

Who is the listed applicant for UREA NITROGEN TEST ITEM NUMBER 65408?

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 UREA NITROGEN TEST ITEM NUMBER 65408?

The FDA product code for UREA NITROGEN TEST ITEM NUMBER 65408 is CDQ.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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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: CDQ)

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.

K203771Urea Nitrogen2Abbott Ireland Diagnostics DivisionK110675EASYRA UREA NITROGEN AND CREATININE REAGENTSMedica Corp.K073295UREA/BUN, SCAL, NORTROL, ABTROLThermofisher Scientific OYK070146ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CPHoriba AbxK060120TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEMTeco DiagnosticsK041051RAICHEM BUN RATE REAGENT (LIQUID)Hemagen Diagnostics, 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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