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FDA 510(k)

ONE TOUCH IIB BLOOD GLUCOSE METER

K-Number: K922888 · 1992-09-15

ApplicantLifescan, Inc.
Decision Date1992-09-15
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ONE TOUCH IIB BLOOD GLUCOSE METER is the device name listed in this FDA 510(k) record. The listed applicant is Lifescan, Inc.. It received FDA 510(k) clearance on 1992-09-15 under 510(k) number K922888. 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 ONE TOUCH IIB BLOOD GLUCOSE METER?

ONE TOUCH IIB BLOOD GLUCOSE METER is a medical device that received FDA 510(k) clearance on 1992-09-15. The listed applicant is Lifescan, Inc.. The 510(k) number is K922888.

When did ONE TOUCH IIB BLOOD GLUCOSE METER receive FDA 510(k) clearance?

ONE TOUCH IIB BLOOD GLUCOSE METER received FDA 510(k) clearance on 1992-09-15, under 510(k) number K922888.

Who is the listed applicant for ONE TOUCH IIB BLOOD GLUCOSE METER?

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

What is the FDA product code for ONE TOUCH IIB BLOOD GLUCOSE METER?

The FDA product code for ONE TOUCH IIB BLOOD GLUCOSE METER is CGA.

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Other records listing Lifescan, 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.

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Related Devices (Code: CGA)

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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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