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FDA 510(k)

PREGNANCY-SKREEN

K-Number: K050328 · 2005-03-29

ApplicantBiochemical Diagnostic, Inc.
Decision Date2005-03-29
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREGNANCY-SKREEN is the device name listed in this FDA 510(k) record. The listed applicant is Biochemical Diagnostic, Inc.. It received FDA 510(k) clearance on 2005-03-29 under 510(k) number K050328. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREGNANCY-SKREEN?

PREGNANCY-SKREEN is a medical device that received FDA 510(k) clearance on 2005-03-29. The listed applicant is Biochemical Diagnostic, Inc.. The 510(k) number is K050328.

When did PREGNANCY-SKREEN receive FDA 510(k) clearance?

PREGNANCY-SKREEN received FDA 510(k) clearance on 2005-03-29, under 510(k) number K050328.

Who is the listed applicant for PREGNANCY-SKREEN?

The FDA 510(k) record lists Biochemical Diagnostic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREGNANCY-SKREEN?

The FDA product code for PREGNANCY-SKREEN is JJX.

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Other records listing Biochemical Diagnostic, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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