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FDA 510(k)

CHEM-STRATE CK-NAC

K-Number: K792477 · 1979-12-27

ApplicantGeneral Diagnostics
Decision Date1979-12-27
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEM-STRATE CK-NAC is the device name listed in this FDA 510(k) record. The listed applicant is General Diagnostics. It received FDA 510(k) clearance on 1979-12-27 under 510(k) number K792477. 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 CHEM-STRATE CK-NAC?

CHEM-STRATE CK-NAC is a medical device that received FDA 510(k) clearance on 1979-12-27. The listed applicant is General Diagnostics. The 510(k) number is K792477.

When did CHEM-STRATE CK-NAC receive FDA 510(k) clearance?

CHEM-STRATE CK-NAC received FDA 510(k) clearance on 1979-12-27, under 510(k) number K792477.

Who is the listed applicant for CHEM-STRATE CK-NAC?

The FDA 510(k) record lists General Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHEM-STRATE CK-NAC?

The FDA product code for CHEM-STRATE CK-NAC is CGS.

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Other records listing General Diagnostics 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.

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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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