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FDA 510(k)

SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483

K-Number: K910639 · 1991-04-12

ApplicantEm Diagnostic Systems, Inc.
Decision Date1991-04-12
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483 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 1991-04-12 under 510(k) number K910639. 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 ALKALINE PHOSPHATASE(EPOS APPL) #65483?

SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483 is a medical device that received FDA 510(k) clearance on 1991-04-12. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K910639.

When did SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483 receive FDA 510(k) clearance?

SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483 received FDA 510(k) clearance on 1991-04-12, under 510(k) number K910639.

Who is the listed applicant for SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483?

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 ALKALINE PHOSPHATASE(EPOS APPL) #65483?

The FDA product code for SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483 is CJE.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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Related Devices (Code: CJE)

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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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