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FDA 510(k)

ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST

K-Number: K980736 · 1998-04-16

ApplicantAcon Laboratories Co.
Decision Date1998-04-16
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Acon Laboratories Co.. It received FDA 510(k) clearance on 1998-04-16 under 510(k) number K980736. 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 ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST?

ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1998-04-16. The listed applicant is Acon Laboratories Co.. The 510(k) number is K980736.

When did ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST receive FDA 510(k) clearance?

ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST received FDA 510(k) clearance on 1998-04-16, under 510(k) number K980736.

Who is the listed applicant for ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST?

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

What is the FDA product code for ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST?

The FDA product code for ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST is JHI.

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Other records listing Acon Laboratories Co. 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.

K090057ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEMK061559ACON URINALYSIS REAGENT STRIPSK023766ACON STREP A TWIST TEST DEVICEK020313ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICEK010582ACON STREP A RAPID TEST STRIP

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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