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FDA 510(k)

ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST

K-Number: K964461 · 1997-02-11

ApplicantTeco Diagnostics
Decision Date1997-02-11
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 1997-02-11 under 510(k) number K964461. 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 URINE/SERUM COMBO PREGNANCY CARD TEST?

ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST is a medical device that received FDA 510(k) clearance on 1997-02-11. The listed applicant is Teco Diagnostics. The 510(k) number is K964461.

When did ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST receive FDA 510(k) clearance?

ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST received FDA 510(k) clearance on 1997-02-11, under 510(k) number K964461.

Who is the listed applicant for ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST?

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

What is the FDA product code for ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST?

The FDA product code for ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST is JHI.

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Other records listing Teco Diagnostics 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.

K170118Scanostics UTI Check Application Test SystemK111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTK100024TECO DIAGNOSTICS UTI DETECTION STRIPSK101673URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERK072548CREATINE KINASE LIQUID REAGENT, MODEL C519-440

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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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