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FDA 510(k)

SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)

K-Number: K894804 · 1989-09-28

ApplicantLifescan, Inc.
Decision Date1989-09-28
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED) is the device name listed in this FDA 510(k) record. The listed applicant is Lifescan, Inc.. It received FDA 510(k) clearance on 1989-09-28 under 510(k) number K894804. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)?

SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED) is a medical device that received FDA 510(k) clearance on 1989-09-28. The listed applicant is Lifescan, Inc.. The 510(k) number is K894804.

When did SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED) receive FDA 510(k) clearance?

SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED) received FDA 510(k) clearance on 1989-09-28, under 510(k) number K894804.

Who is the listed applicant for SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)?

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 SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)?

The FDA product code for SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED) is JJX.

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Related Devices (Code: JJX)

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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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