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FDA 510(k)

MODEL UCG ASSAY

K-Number: K822520 · 1982-09-28

ApplicantMonoclonal Antibodies, Inc.
Decision Date1982-09-28
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODEL UCG 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 1982-09-28 under 510(k) number K822520. 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 MODEL UCG ASSAY?

MODEL UCG ASSAY is a medical device that received FDA 510(k) clearance on 1982-09-28. The listed applicant is Monoclonal Antibodies, Inc.. The 510(k) number is K822520.

When did MODEL UCG ASSAY receive FDA 510(k) clearance?

MODEL UCG ASSAY received FDA 510(k) clearance on 1982-09-28, under 510(k) number K822520.

Who is the listed applicant for MODEL UCG 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 MODEL UCG ASSAY?

The FDA product code for MODEL UCG 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 KITK854611RAMP URINE HCG ASSAYK850730MODEL SERUM HCG ASSAY

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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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