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FDA 510(k)

ARIA II I-HCG

K-Number: K830997 · 1983-06-02

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1983-06-02
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARIA II I-HCG is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1983-06-02 under 510(k) number K830997. 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 ARIA II I-HCG?

ARIA II I-HCG is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K830997.

When did ARIA II I-HCG receive FDA 510(k) clearance?

ARIA II I-HCG received FDA 510(k) clearance on 1983-06-02, under 510(k) number K830997.

Who is the listed applicant for ARIA II I-HCG?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARIA II I-HCG?

The FDA product code for ARIA II I-HCG is JHI.

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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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