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FDA 510(k)

OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP

K-Number: K930185 · 1993-03-04

ApplicantPrinceton Biomedix
Decision Date1993-03-04
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP is the device name listed in this FDA 510(k) record. The listed applicant is Princeton Biomedix. It received FDA 510(k) clearance on 1993-03-04 under 510(k) number K930185. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP?

OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP is a medical device that received FDA 510(k) clearance on 1993-03-04. The listed applicant is Princeton Biomedix. The 510(k) number is K930185.

When did OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP receive FDA 510(k) clearance?

OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP received FDA 510(k) clearance on 1993-03-04, under 510(k) number K930185.

Who is the listed applicant for OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP?

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

What is the FDA product code for OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP?

The FDA product code for OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP is CEP.

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Other records listing Princeton Biomedix 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.

K942052LIFESIGN MI MYOGLOBINK925355BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TESTK925183BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TESTK926308LIFESIGN HCG - ONE STEP HOME PREGNANCY TESTK901011BIOSIGN HCG-ONE STEP PREGNANCY TESTK894705BIOSPOT HCG-RAPID PREGNANCY TEST

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Related Devices (Code: CEP)

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.

K013582MAYBE?MOM MINI OVULATION MICROSCOPEMaybe?MomK022829INSTANT-VIEW LH OVULATION PREDICTING TESTAlfa Scientific Designs, Inc.K021409AT HOME OVULATION TEST, MODEL 9032Phamatech, Inc.K013874CLEARPLANE EASY OVULATION TESTUnipath , Ltd.K013323TCI-31 LIFELONG OVULATION TESTERTci New YorkK012252QUIK-CHECK OVULATION PREDICTORACON Laboratories, Inc.

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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