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FDA 510(k)

BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST

K-Number: K950307 · 1995-03-01

ApplicantPrinceton BioMeditech Corp.
Decision Date1995-03-01
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 1995-03-01 under 510(k) number K950307. 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 BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST?

BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1995-03-01. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K950307.

When did BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST receive FDA 510(k) clearance?

BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST received FDA 510(k) clearance on 1995-03-01, under 510(k) number K950307.

Who is the listed applicant for BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST?

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

What is the FDA product code for BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST?

The FDA product code for BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST is DHA.

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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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