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FDA 510(k)

EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410

K-Number: K893916 · 1989-08-28

ApplicantEm Diagnostic Systems, Inc.
Decision Date1989-08-28
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410 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 1989-08-28 under 510(k) number K893916. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410?

EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410 is a medical device that received FDA 510(k) clearance on 1989-08-28. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K893916.

When did EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410 receive FDA 510(k) clearance?

EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410 received FDA 510(k) clearance on 1989-08-28, under 510(k) number K893916.

Who is the listed applicant for EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410?

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 CHOLESTEROL (CHO), ITEM NUMBER 65410?

The FDA product code for EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410 is CHH.

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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: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, 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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