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FDA 510(k)

DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)

K-Number: K033851 · 2004-03-02

ApplicantHypoguard USA, Inc.
Decision Date2004-03-02
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) is the device name listed in this FDA 510(k) record. The listed applicant is Hypoguard USA, Inc.. It received FDA 510(k) clearance on 2004-03-02 under 510(k) number K033851. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)?

DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) is a medical device that received FDA 510(k) clearance on 2004-03-02. The listed applicant is Hypoguard USA, Inc.. The 510(k) number is K033851.

When did DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) receive FDA 510(k) clearance?

DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) received FDA 510(k) clearance on 2004-03-02, under 510(k) number K033851.

Who is the listed applicant for DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)?

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

What is the FDA product code for DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)?

The FDA product code for DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) is JIL.

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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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