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FDA 510(k)

PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL

K-Number: K960855 · 1996-11-07

ApplicantHome Diagnostics, Inc.
Decision Date1996-11-07
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Home Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-11-07 under 510(k) number K960855. 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 PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL?

PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL is a medical device that received FDA 510(k) clearance on 1996-11-07. The listed applicant is Home Diagnostics, Inc.. The 510(k) number is K960855.

When did PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL receive FDA 510(k) clearance?

PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL received FDA 510(k) clearance on 1996-11-07, under 510(k) number K960855.

Who is the listed applicant for PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL?

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

What is the FDA product code for PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL?

The FDA product code for PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL is CGA.

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Other records listing Home Diagnostics, Inc. 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.

K090495TRUEBALANCE BLOOD GLUCOSE SYSTEMK080641TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81K080710TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81K070593TRACKRECORD DATA MANAGEMENT SOFTWAREK060793ELEMENT BLOOD GLUCOSE TEST SYSTEMK051147SIDEKICK BLOOD GLUCOSE TEST SYSTEM

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Related Devices (Code: CGA)

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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