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FDA 510(k)

SATURN BLOOD GLUCOSE MONITORING TEST STRIP

K-Number: K001441 · 2000-12-18

ApplicantLifescan, Inc.
Decision Date2000-12-18
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SATURN BLOOD GLUCOSE MONITORING TEST STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Lifescan, Inc.. It received FDA 510(k) clearance on 2000-12-18 under 510(k) number K001441. 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 SATURN BLOOD GLUCOSE MONITORING TEST STRIP?

SATURN BLOOD GLUCOSE MONITORING TEST STRIP is a medical device that received FDA 510(k) clearance on 2000-12-18. The listed applicant is Lifescan, Inc.. The 510(k) number is K001441.

When did SATURN BLOOD GLUCOSE MONITORING TEST STRIP receive FDA 510(k) clearance?

SATURN BLOOD GLUCOSE MONITORING TEST STRIP received FDA 510(k) clearance on 2000-12-18, under 510(k) number K001441.

Who is the listed applicant for SATURN BLOOD GLUCOSE MONITORING TEST STRIP?

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 SATURN BLOOD GLUCOSE MONITORING TEST STRIP?

The FDA product code for SATURN BLOOD GLUCOSE MONITORING TEST STRIP 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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