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FDA 510(k)

AIMSTICK URINE REAGENT STRIPS

K-Number: K051727 · 2005-10-26

ApplicantGermaine Laboratories, Inc.
Decision Date2005-10-26
Product CodeCEN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AIMSTICK URINE REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Germaine Laboratories, Inc.. It received FDA 510(k) clearance on 2005-10-26 under 510(k) number K051727. The device is classified under product code CEN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIMSTICK URINE REAGENT STRIPS?

AIMSTICK URINE REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 2005-10-26. The listed applicant is Germaine Laboratories, Inc.. The 510(k) number is K051727.

When did AIMSTICK URINE REAGENT STRIPS receive FDA 510(k) clearance?

AIMSTICK URINE REAGENT STRIPS received FDA 510(k) clearance on 2005-10-26, under 510(k) number K051727.

Who is the listed applicant for AIMSTICK URINE REAGENT STRIPS?

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

What is the FDA product code for AIMSTICK URINE REAGENT STRIPS?

The FDA product code for AIMSTICK URINE REAGENT STRIPS is CEN.

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Other records listing Germaine Laboratories, 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.

K013857AIMSTEP PREGNANCYK991369ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCYK981165AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TESTK980531AIMSTEP PREGNANCYK974512AIMSTICK PBD COMBO PREGNANCYK974368AIMSTICK PBD PREGNANCY

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Related Devices (Code: CEN)

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.

K091287VS-SENSE TESTCommon Sense , Ltd.K071100AMNISCREEN HOME DETECTION LINER KITCommon Sense , Ltd.K040008QUICKVUE ADVANCE PH AND AMINES GLL TESTQuidel Corp.K030650STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONSUridynamics, Inc.K962718FEMEXAM TESTCARDLitmus Concepts, Inc.K840827KYOTEST 5VKyoto Diagnostics, Inc.

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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