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FDA 510(k)

EMDS(TM) ALBUMIN TESTPACKS, #67652/95

K-Number: K863004 · 1986-09-16

ApplicantEm Diagnostic Systems, Inc.
Decision Date1986-09-16
Product CodeCJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMDS(TM) ALBUMIN TESTPACKS, #67652/95 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 1986-09-16 under 510(k) number K863004. The device is classified under product code CJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMDS(TM) ALBUMIN TESTPACKS, #67652/95?

EMDS(TM) ALBUMIN TESTPACKS, #67652/95 is a medical device that received FDA 510(k) clearance on 1986-09-16. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K863004.

When did EMDS(TM) ALBUMIN TESTPACKS, #67652/95 receive FDA 510(k) clearance?

EMDS(TM) ALBUMIN TESTPACKS, #67652/95 received FDA 510(k) clearance on 1986-09-16, under 510(k) number K863004.

Who is the listed applicant for EMDS(TM) ALBUMIN TESTPACKS, #67652/95?

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(TM) ALBUMIN TESTPACKS, #67652/95?

The FDA product code for EMDS(TM) ALBUMIN TESTPACKS, #67652/95 is CJW.

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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: CJW)

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.

K203530Albumin BCP2Abbott Ireland Diagnostics DivisionK193001Albumin BCPSENTINEL CH. SpAK132664ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATORSiemens Healthcare Diagnostics, Inc.K021636ALBUMIN REAGENTIntersect Systems, Inc.K000483RANDOX ALBUMINRandox Laboratories, Ltd.K990978ALBUMIN BCG, MODEL AL 103-01A.P. Total Care, 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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