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FDA 510(k)

ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16

K-Number: K913025 · 1991-10-09

ApplicantEm Diagnostic Systems, Inc.
Decision Date1991-10-09
Product CodeCJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 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 1991-10-09 under 510(k) number K913025. 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 ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16?

ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 is a medical device that received FDA 510(k) clearance on 1991-10-09. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K913025.

When did ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 receive FDA 510(k) clearance?

ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 received FDA 510(k) clearance on 1991-10-09, under 510(k) number K913025.

Who is the listed applicant for ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16?

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 ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16?

The FDA product code for ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 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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