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FDA 510(k)

EMDS PHOSPHOROUS (PHOS) TEST

K-Number: K935178 · 1993-12-17

ApplicantEm Diagnostic Systems, Inc.
Decision Date1993-12-17
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMDS PHOSPHOROUS (PHOS) TEST 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 1993-12-17 under 510(k) number K935178. 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 EMDS PHOSPHOROUS (PHOS) TEST?

EMDS PHOSPHOROUS (PHOS) TEST is a medical device that received FDA 510(k) clearance on 1993-12-17. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K935178.

When did EMDS PHOSPHOROUS (PHOS) TEST receive FDA 510(k) clearance?

EMDS PHOSPHOROUS (PHOS) TEST received FDA 510(k) clearance on 1993-12-17, under 510(k) number K935178.

Who is the listed applicant for EMDS PHOSPHOROUS (PHOS) TEST?

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 PHOSPHOROUS (PHOS) TEST?

The FDA product code for EMDS PHOSPHOROUS (PHOS) TEST 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) TESTK935179EMDS ALBUMIN (ALB) TESTK935174TOTAL PROTEIN TEST (TPRO)K935175LACTATE DEHYDROGENASE (LD)K935176IRON TEST

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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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