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FDA 510(k)

SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205

K-Number: K852483 · 1985-07-12

ApplicantEm Diagnostic Systems, Inc.
Decision Date1985-07-12
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205 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 1985-07-12 under 510(k) number K852483. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205?

SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205 is a medical device that received FDA 510(k) clearance on 1985-07-12. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K852483.

When did SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205 receive FDA 510(k) clearance?

SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205 received FDA 510(k) clearance on 1985-07-12, under 510(k) number K852483.

Who is the listed applicant for SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205?

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 CK-MB(NAC-ACTIVATED) ITEM NO. 67205?

The FDA product code for SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205 is CGS.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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Related Devices (Code: CGS)

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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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