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FDA 510(k)

RAMP URINE HCG ASSAY

K-Number: K854611 · 1985-12-30

ApplicantMonoclonal Antibodies, Inc.
Decision Date1985-12-30
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAMP URINE HCG ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Monoclonal Antibodies, Inc.. It received FDA 510(k) clearance on 1985-12-30 under 510(k) number K854611. 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 RAMP URINE HCG ASSAY?

RAMP URINE HCG ASSAY is a medical device that received FDA 510(k) clearance on 1985-12-30. The listed applicant is Monoclonal Antibodies, Inc.. The 510(k) number is K854611.

When did RAMP URINE HCG ASSAY receive FDA 510(k) clearance?

RAMP URINE HCG ASSAY received FDA 510(k) clearance on 1985-12-30, under 510(k) number K854611.

Who is the listed applicant for RAMP URINE HCG ASSAY?

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

What is the FDA product code for RAMP URINE HCG ASSAY?

The FDA product code for RAMP URINE HCG ASSAY is JHI.

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Other records listing Monoclonal Antibodies, 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.

K874863RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)K871726OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)K863744HCG CONTROL KITK860924RAMP PROGESTURINE PDG ASSAY--48 TEST KITK850730MODEL SERUM HCG ASSAYK850480OVU STICK SELF-TEST -MODIFICATION

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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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