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FDA 510(k)

ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT

K-Number: K955353 · 1996-03-19

ApplicantTcpi, Inc.
Decision Date1996-03-19
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Tcpi, Inc.. It received FDA 510(k) clearance on 1996-03-19 under 510(k) number K955353. 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 PREGNANCY HCG SERUN DILUENT REAGENT?

ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT is a medical device that received FDA 510(k) clearance on 1996-03-19. The listed applicant is Tcpi, Inc.. The 510(k) number is K955353.

When did ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT receive FDA 510(k) clearance?

ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT received FDA 510(k) clearance on 1996-03-19, under 510(k) number K955353.

Who is the listed applicant for ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT?

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

What is the FDA product code for ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT?

The FDA product code for ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT is JHI.

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Other records listing Tcpi, Inc. 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.

K981363ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TESTK972960HEALTH CHECK URI-TEST PROTEIN IN URINEK981197ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TESTK980776ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TESTK951853ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)K954968HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST

View all 14 devices →

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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