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FDA 510(k)

AIMSTICK PBD COMBO PREGNANCY

K-Number: K974512 · 1998-01-02

ApplicantGermaine Laboratories, Inc.
Decision Date1998-01-02
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AIMSTICK PBD COMBO 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 1998-01-02 under 510(k) number K974512. 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 AIMSTICK PBD COMBO PREGNANCY?

AIMSTICK PBD COMBO PREGNANCY is a medical device that received FDA 510(k) clearance on 1998-01-02. The listed applicant is Germaine Laboratories, Inc.. The 510(k) number is K974512.

When did AIMSTICK PBD COMBO PREGNANCY receive FDA 510(k) clearance?

AIMSTICK PBD COMBO PREGNANCY received FDA 510(k) clearance on 1998-01-02, under 510(k) number K974512.

Who is the listed applicant for AIMSTICK PBD COMBO 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 AIMSTICK PBD COMBO PREGNANCY?

The FDA product code for AIMSTICK PBD COMBO 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 STRIPSK013857AIMSTEP PREGNANCYK991369ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCYK981165AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TESTK980531AIMSTEP 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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