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FDA 510(k)

STC AUTO-LYTE URINARY GLUCOSE ASSAY

K-Number: K962435 · 1996-12-26

ApplicantOraSure Technologies, Inc.
Decision Date1996-12-26
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STC AUTO-LYTE URINARY GLUCOSE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is OraSure Technologies, Inc.. It received FDA 510(k) clearance on 1996-12-26 under 510(k) number K962435. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STC AUTO-LYTE URINARY GLUCOSE ASSAY?

STC AUTO-LYTE URINARY GLUCOSE ASSAY is a medical device that received FDA 510(k) clearance on 1996-12-26. The listed applicant is OraSure Technologies, Inc.. The 510(k) number is K962435.

When did STC AUTO-LYTE URINARY GLUCOSE ASSAY receive FDA 510(k) clearance?

STC AUTO-LYTE URINARY GLUCOSE ASSAY received FDA 510(k) clearance on 1996-12-26, under 510(k) number K962435.

Who is the listed applicant for STC AUTO-LYTE URINARY GLUCOSE ASSAY?

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

What is the FDA product code for STC AUTO-LYTE URINARY GLUCOSE ASSAY?

The FDA product code for STC AUTO-LYTE URINARY GLUCOSE ASSAY is CFR.

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Related Devices (Code: CFR)

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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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