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FDA 510(k)

PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST

K-Number: K982303 · 1998-12-08

ApplicantMedisense, Inc.
Decision Date1998-12-08
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST is the device name listed in this FDA 510(k) record. The listed applicant is Medisense, Inc.. It received FDA 510(k) clearance on 1998-12-08 under 510(k) number K982303. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST?

PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST is a medical device that received FDA 510(k) clearance on 1998-12-08. The listed applicant is Medisense, Inc.. The 510(k) number is K982303.

When did PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST receive FDA 510(k) clearance?

PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST received FDA 510(k) clearance on 1998-12-08, under 510(k) number K982303.

Who is the listed applicant for PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST?

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

What is the FDA product code for PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST?

The FDA product code for PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST is CGA.

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Other records listing Medisense, Inc. as applicant

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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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