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FDA 510(k)

I.C.L.S. COMPULYZER

K-Number: K854055 · 1985-11-19

ApplicantIntegrated Computerized Laboratory Systems, Inc.
Decision Date1985-11-19
Product CodeJJG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

I.C.L.S. COMPULYZER is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Computerized Laboratory Systems, Inc.. It received FDA 510(k) clearance on 1985-11-19 under 510(k) number K854055. 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 I.C.L.S. COMPULYZER?

I.C.L.S. COMPULYZER is a medical device that received FDA 510(k) clearance on 1985-11-19. The listed applicant is Integrated Computerized Laboratory Systems, Inc.. The 510(k) number is K854055.

When did I.C.L.S. COMPULYZER receive FDA 510(k) clearance?

I.C.L.S. COMPULYZER received FDA 510(k) clearance on 1985-11-19, under 510(k) number K854055.

Who is the listed applicant for I.C.L.S. COMPULYZER?

The FDA 510(k) record lists Integrated Computerized Laboratory Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I.C.L.S. COMPULYZER?

The FDA product code for I.C.L.S. COMPULYZER is JJG.

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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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