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FDA 510(k)

EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95

K-Number: K870571 · 1987-03-04

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-03-04
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95 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 1987-03-04 under 510(k) number K870571. 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 EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95?

EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95 is a medical device that received FDA 510(k) clearance on 1987-03-04. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K870571.

When did EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95 receive FDA 510(k) clearance?

EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95 received FDA 510(k) clearance on 1987-03-04, under 510(k) number K870571.

Who is the listed applicant for EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95?

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 EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95?

The FDA product code for EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95 is CDQ.

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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: 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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