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FDA 510(k)

ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY

K-Number: K991369 · 1999-05-10

ApplicantGermaine Laboratories, Inc.
Decision Date1999-05-10
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY 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 1999-05-10 under 510(k) number K991369. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY?

ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY is a medical device that received FDA 510(k) clearance on 1999-05-10. The listed applicant is Germaine Laboratories, Inc.. The 510(k) number is K991369.

When did ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY receive FDA 510(k) clearance?

ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY received FDA 510(k) clearance on 1999-05-10, under 510(k) number K991369.

Who is the listed applicant for ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY?

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 ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY?

The FDA product code for ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY is LCX.

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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.

K051727AIMSTICK URINE REAGENT STRIPSK013857AIMSTEP PREGNANCYK981165AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TESTK980531AIMSTEP PREGNANCYK974512AIMSTICK PBD COMBO PREGNANCYK974368AIMSTICK PBD PREGNANCY

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Related Devices (Code: LCX)

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.

K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestGuangzhou Decheng Biotechnology Co., Ltd.K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd.K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLCK242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test MidstreamNanjing Synthgene Medical Technology Co., Ltd.K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamAssure Tech., LLCK241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.

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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