Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402

K-Number: K895250 · 1989-10-31

ApplicantEm Diagnostic Systems, Inc.
Decision Date1989-10-31
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402 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 1989-10-31 under 510(k) number K895250. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402?

SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402 is a medical device that received FDA 510(k) clearance on 1989-10-31. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K895250.

When did SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402 receive FDA 510(k) clearance?

SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402 received FDA 510(k) clearance on 1989-10-31, under 510(k) number K895250.

Who is the listed applicant for SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402?

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 SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402?

The FDA product code for SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402 is CJE.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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)

View all 288 devices →

Related Devices (Code: CJE)

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.

K251074Tru Liver Health Test PanelTruvian HealthK240468Alkaline PhosphataseAbbott Laboratories Diagnostics DivisionK223317Alkaline Phosphatase2Abbott Ireland Diagnostics DivisionK191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHORIBA ABX SASK171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry AnalyzerLite-On Technology Corp. H.S.P.B.K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)

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.

↑