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FDA 510(k)

ONE-STEP DOUBLE-CHEK PREGNANCY TEST

K-Number: K992915 · 1999-11-18

ApplicantBiomedical Products Corp.
Decision Date1999-11-18
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ONE-STEP DOUBLE-CHEK PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Products Corp.. It received FDA 510(k) clearance on 1999-11-18 under 510(k) number K992915. 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 ONE-STEP DOUBLE-CHEK PREGNANCY TEST?

ONE-STEP DOUBLE-CHEK PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1999-11-18. The listed applicant is Biomedical Products Corp.. The 510(k) number is K992915.

When did ONE-STEP DOUBLE-CHEK PREGNANCY TEST receive FDA 510(k) clearance?

ONE-STEP DOUBLE-CHEK PREGNANCY TEST received FDA 510(k) clearance on 1999-11-18, under 510(k) number K992915.

Who is the listed applicant for ONE-STEP DOUBLE-CHEK PREGNANCY TEST?

The FDA 510(k) record lists Biomedical Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONE-STEP DOUBLE-CHEK PREGNANCY TEST?

The FDA product code for ONE-STEP DOUBLE-CHEK PREGNANCY TEST is JHI.

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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.

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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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