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FDA 510(k)

IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X

K-Number: K874033 · 1988-01-05

ApplicantDiagnostic Products Corp.
Decision Date1988-01-05
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1988-01-05 under 510(k) number K874033. 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 IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X?

IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X is a medical device that received FDA 510(k) clearance on 1988-01-05. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K874033.

When did IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X receive FDA 510(k) clearance?

IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X received FDA 510(k) clearance on 1988-01-05, under 510(k) number K874033.

Who is the listed applicant for IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X?

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

What is the FDA product code for IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X?

The FDA product code for IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X is JHI.

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Other records listing Diagnostic Products Corp. as applicant

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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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