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FDA 510(k)

CLINIFACTS 200 DATA MANAGEMENT SYSTEM

K-Number: K861778 · 1986-07-02

ApplicantMiles Laboratories, Inc.
Decision Date1986-07-02
Product CodeJQP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINIFACTS 200 DATA MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1986-07-02 under 510(k) number K861778. The device is classified under product code JQP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINIFACTS 200 DATA MANAGEMENT SYSTEM?

CLINIFACTS 200 DATA MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1986-07-02. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K861778.

When did CLINIFACTS 200 DATA MANAGEMENT SYSTEM receive FDA 510(k) clearance?

CLINIFACTS 200 DATA MANAGEMENT SYSTEM received FDA 510(k) clearance on 1986-07-02, under 510(k) number K861778.

Who is the listed applicant for CLINIFACTS 200 DATA MANAGEMENT SYSTEM?

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

What is the FDA product code for CLINIFACTS 200 DATA MANAGEMENT SYSTEM?

The FDA product code for CLINIFACTS 200 DATA MANAGEMENT SYSTEM is JQP.

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Other records listing Miles Laboratories, Inc. as applicant

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Related Devices (Code: JQP)

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K113007BIONIME DIABETES MANAGEMENT SYSTEM VI.0Bionime CorporationK983468FASTTAKE ADAPTER, MODEL # P/N 020-072-01Selfcare, Inc.K964460THE ROBOLITEShai Syg Motion and Innovations, Ltd.K953652PRENVAL IBase Ten Systems, Inc.K934111MR7000 WITH TIME MANAGER SOFTWARE (TMS)Dynatech Laboratories, Inc.K923316EXPRESSO CARTRIDGEBio-Rad Laboratories, 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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