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FDA 510(k)

ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651

K-Number: K884549 · 1988-11-10

ApplicantEm Diagnostic Systems, Inc.
Decision Date1988-11-10
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651 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 1988-11-10 under 510(k) number K884549. 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 ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651?

ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651 is a medical device that received FDA 510(k) clearance on 1988-11-10. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K884549.

When did ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651 receive FDA 510(k) clearance?

ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651 received FDA 510(k) clearance on 1988-11-10, under 510(k) number K884549.

Who is the listed applicant for ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651?

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 ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651?

The FDA product code for ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651 is CJE.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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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.

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