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FDA 510(k)

AIMSTEP PREGNANCY

K-Number: K980531 · 1998-03-06

ApplicantGermaine Laboratories, Inc.
Decision Date1998-03-06
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AIMSTEP 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 1998-03-06 under 510(k) number K980531. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIMSTEP PREGNANCY?

AIMSTEP PREGNANCY is a medical device that received FDA 510(k) clearance on 1998-03-06. The listed applicant is Germaine Laboratories, Inc.. The 510(k) number is K980531.

When did AIMSTEP PREGNANCY receive FDA 510(k) clearance?

AIMSTEP PREGNANCY received FDA 510(k) clearance on 1998-03-06, under 510(k) number K980531.

Who is the listed applicant for AIMSTEP 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 AIMSTEP PREGNANCY?

The FDA product code for AIMSTEP PREGNANCY is JHI.

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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 PREGNANCYK991369ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCYK981165AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TESTK974368AIMSTICK PBD PREGNANCYK974512AIMSTICK PBD COMBO PREGNANCY

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Related Devices (Code: JHI)

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.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. 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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