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FDA 510(k)

EASY-TEST CREATINE KINASE (CK) NUMBER: 16614

K-Number: K870461 · 1987-03-06

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-03-06
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASY-TEST CREATINE KINASE (CK) NUMBER: 16614 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 1987-03-06 under 510(k) number K870461. 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 EASY-TEST CREATINE KINASE (CK) NUMBER: 16614?

EASY-TEST CREATINE KINASE (CK) NUMBER: 16614 is a medical device that received FDA 510(k) clearance on 1987-03-06. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K870461.

When did EASY-TEST CREATINE KINASE (CK) NUMBER: 16614 receive FDA 510(k) clearance?

EASY-TEST CREATINE KINASE (CK) NUMBER: 16614 received FDA 510(k) clearance on 1987-03-06, under 510(k) number K870461.

Who is the listed applicant for EASY-TEST CREATINE KINASE (CK) NUMBER: 16614?

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 EASY-TEST CREATINE KINASE (CK) NUMBER: 16614?

The FDA product code for EASY-TEST CREATINE KINASE (CK) NUMBER: 16614 is CGS.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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Related Devices (Code: CGS)

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.

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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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