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FDA 510(k)

ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.

K-Number: K052694 · 2005-12-16

ApplicantInd Diagnostic, Inc.
Decision Date2005-12-16
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. is the device name listed in this FDA 510(k) record. The listed applicant is Ind Diagnostic, Inc.. It received FDA 510(k) clearance on 2005-12-16 under 510(k) number K052694. 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 HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.?

ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. is a medical device that received FDA 510(k) clearance on 2005-12-16. The listed applicant is Ind Diagnostic, Inc.. The 510(k) number is K052694.

When did ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. receive FDA 510(k) clearance?

ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. received FDA 510(k) clearance on 2005-12-16, under 510(k) number K052694.

Who is the listed applicant for ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.?

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

What is the FDA product code for ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.?

The FDA product code for ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. is JHI.

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Other records listing Ind Diagnostic, 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.

K103037IND URINARY TRACT INFECTION (UTI) TEST STRIPSK100031IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10K063390URINE CHEMISTRY ANALYZER UR-50K060810ONE STEP DRUG TEST - AMP/MET/MOR/THC/COCK052662ONE STEP FSH MENOPAUSAL TESTK050741IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT

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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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