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FDA 510(k)

BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE

K-Number: K944426 · 1994-10-25

ApplicantPrinceton BioMeditech Corp.
Decision Date1994-10-25
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE 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 1994-10-25 under 510(k) number K944426. 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 BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE?

BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE is a medical device that received FDA 510(k) clearance on 1994-10-25. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K944426.

When did BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE receive FDA 510(k) clearance?

BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE received FDA 510(k) clearance on 1994-10-25, under 510(k) number K944426.

Who is the listed applicant for BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE?

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 BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE?

The FDA product code for BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE is JHI.

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Other records listing Princeton BioMeditech Corp. 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.

K251538Status™ COVID-19/Flu A&BK182157BioSign Flu A+BK133474BIOSIGN FLU A + B, STATUS FLU A & BK132465BIOSIGN FLU A + B, STATUS FLU A & BK083746BIOSIGN FLU A+BK100817BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST

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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.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.

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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