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FDA 510(k)

AIMSTEP PREGNANCY

K-Number: K013857 · 2002-01-22

ApplicantGermaine Laboratories, Inc.
Decision Date2002-01-22
Product CodeDHA
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 2002-01-22 under 510(k) number K013857. The device is classified under product code DHA. 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 2002-01-22. The listed applicant is Germaine Laboratories, Inc.. The 510(k) number is K013857.

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

AIMSTEP PREGNANCY received FDA 510(k) clearance on 2002-01-22, under 510(k) number K013857.

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 DHA.

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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 STRIPSK991369ACCUDIP 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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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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