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FDA 510(k)

PHOSPHORUS TEST (PHOS) ITEM #65666

K-Number: K884735 · 1988-12-16

ApplicantEm Diagnostic Systems, Inc.
Decision Date1988-12-16
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHOSPHORUS TEST (PHOS) ITEM #65666 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 1988-12-16 under 510(k) number K884735. The device is classified under product code CEO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOSPHORUS TEST (PHOS) ITEM #65666?

PHOSPHORUS TEST (PHOS) ITEM #65666 is a medical device that received FDA 510(k) clearance on 1988-12-16. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K884735.

When did PHOSPHORUS TEST (PHOS) ITEM #65666 receive FDA 510(k) clearance?

PHOSPHORUS TEST (PHOS) ITEM #65666 received FDA 510(k) clearance on 1988-12-16, under 510(k) number K884735.

Who is the listed applicant for PHOSPHORUS TEST (PHOS) ITEM #65666?

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 PHOSPHORUS TEST (PHOS) ITEM #65666?

The FDA product code for PHOSPHORUS TEST (PHOS) ITEM #65666 is CEO.

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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: CEO)

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.

K100263ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSSeppim S.A.S.K072141S40 CLINICAL ANALYZER, S TEST IP, S TEST UAAlfa Wassermann Diagnostic Technologies, Inc.K041643SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENTBeckman Coulter, Inc.K030015ATAC PAK PHOSPHORUS REAGENTElan DiagnosticsK022312PICCOLO PHOSPHORUS TEST SYSTEMAbaxis, Inc.K013095WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311Wiener 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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