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FDA 510(k)

CENTRIFICHEM SYS 400 ANALYZER

K-Number: K771813 · 1977-10-25

ApplicantClinical Diagnostics, Inc.
Decision Date1977-10-25
Product CodeJJG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CENTRIFICHEM SYS 400 ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 1977-10-25 under 510(k) number K771813. The device is classified under product code JJG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRIFICHEM SYS 400 ANALYZER?

CENTRIFICHEM SYS 400 ANALYZER is a medical device that received FDA 510(k) clearance on 1977-10-25. The listed applicant is Clinical Diagnostics, Inc.. The 510(k) number is K771813.

When did CENTRIFICHEM SYS 400 ANALYZER receive FDA 510(k) clearance?

CENTRIFICHEM SYS 400 ANALYZER received FDA 510(k) clearance on 1977-10-25, under 510(k) number K771813.

Who is the listed applicant for CENTRIFICHEM SYS 400 ANALYZER?

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

What is the FDA product code for CENTRIFICHEM SYS 400 ANALYZER?

The FDA product code for CENTRIFICHEM SYS 400 ANALYZER is JJG.

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Other records listing Clinical Diagnostics, Inc. as applicant

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K971653GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEMK951457GLUCOCHEK POCKETLABK940215GLUCOCHEKK854903GORDON DIAGNOSTIC SYSTEM MODEL IK771118CENTRIA SEPARATION COLUMNS TYPE AK771117CENTRIA CORTISOL RIA

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Related Devices (Code: JJG)

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.

K972409AG CHEMISTRY ANALYZER SYSTEMLandmark Scientific, Inc.K942782PICCOLO(TM)Abaxis, Inc.K934592EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTORAbaxis, Inc.K920942OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZEROlympus Corp.K910222COBAS ALPHARoche Diagnostic Systems, Inc.K903626BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISABeckman Instruments, Inc.

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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