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FDA 510(k)

MIDSTREAM HOME REGNANCY TEST

K-Number: K973825 · 1997-12-19

ApplicantGermaine Laboratories, Inc.
Decision Date1997-12-19
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MIDSTREAM HOME REGNANCY TEST 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 1997-12-19 under 510(k) number K973825. 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 MIDSTREAM HOME REGNANCY TEST?

MIDSTREAM HOME REGNANCY TEST is a medical device that received FDA 510(k) clearance on 1997-12-19. The listed applicant is Germaine Laboratories, Inc.. The 510(k) number is K973825.

When did MIDSTREAM HOME REGNANCY TEST receive FDA 510(k) clearance?

MIDSTREAM HOME REGNANCY TEST received FDA 510(k) clearance on 1997-12-19, under 510(k) number K973825.

Who is the listed applicant for MIDSTREAM HOME REGNANCY TEST?

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 MIDSTREAM HOME REGNANCY TEST?

The FDA product code for MIDSTREAM HOME REGNANCY TEST 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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