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FDA 510(k)

HCG ACCU-STICK

K-Number: K831604 · 1983-07-19

ApplicantBtc Diagnostics, Inc.
Decision Date1983-07-19
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HCG ACCU-STICK is the device name listed in this FDA 510(k) record. The listed applicant is Btc Diagnostics, Inc.. It received FDA 510(k) clearance on 1983-07-19 under 510(k) number K831604. 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 HCG ACCU-STICK?

HCG ACCU-STICK is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is Btc Diagnostics, Inc.. The 510(k) number is K831604.

When did HCG ACCU-STICK receive FDA 510(k) clearance?

HCG ACCU-STICK received FDA 510(k) clearance on 1983-07-19, under 510(k) number K831604.

Who is the listed applicant for HCG ACCU-STICK?

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

What is the FDA product code for HCG ACCU-STICK?

The FDA product code for HCG ACCU-STICK is JHI.

Related Clinical Trials

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.

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Other records listing Btc Diagnostics, 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.

K841545ENZYME IMMUNOASSAY FOR DETECTION HORMK832905QUALITATIVE ENZYME IMMUNOASSAY-DETECTK833710BTC URINE LH ASSAYK831125BTC URINE LCG ASSAY

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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