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FDA 510(k)

BHCG RIA KIT

K-Number: K831264 · 1983-06-08

ApplicantMicromedic Systems
Decision Date1983-06-08
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BHCG RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Micromedic Systems. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831264. 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 BHCG RIA KIT?

BHCG RIA KIT is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Micromedic Systems. The 510(k) number is K831264.

When did BHCG RIA KIT receive FDA 510(k) clearance?

BHCG RIA KIT received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831264.

Who is the listed applicant for BHCG RIA KIT?

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

What is the FDA product code for BHCG RIA KIT?

The FDA product code for BHCG RIA KIT is JHI.

Other records listing Micromedic Systems 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.

K923643MEDICOOLK872309MICROMEDIC COMBOSTAT LH/FSH KITK870904MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KITK871008MICROMEDIC NEONATAL T4 KITK871505AUTOPAK NEONATAL TSH MONOCLONAL IRMA KITK870245AUTOPAK TSH MONOCLONAL IRMA KIT

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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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