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FDA 510(k)

PLUS URINE HCG ASSAY

K-Number: K840738 · 1984-04-19

ApplicantMonoclonal Antibodies, Inc.
Decision Date1984-04-19
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PLUS 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 1984-04-19 under 510(k) number K840738. The device is classified under product code JHJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLUS URINE HCG ASSAY?

PLUS URINE HCG ASSAY is a medical device that received FDA 510(k) clearance on 1984-04-19. The listed applicant is Monoclonal Antibodies, Inc.. The 510(k) number is K840738.

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

PLUS URINE HCG ASSAY received FDA 510(k) clearance on 1984-04-19, under 510(k) number K840738.

Who is the listed applicant for PLUS 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 PLUS URINE HCG ASSAY?

The FDA product code for PLUS URINE HCG ASSAY is JHJ.

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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: JHJ)

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.

K972606PREGNACOL PREGNANCY TESTImmunostics Inc.,K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTTech-Co, Inc.K935863SAS(TM) DIRECT MONOCLONAL HCGSa Scientific, Inc.K926112ACCUTEX BETA-HCG TESTJ.S. Medical Assoc.K930609SAS(TM) MONOCLONAL HCG-SLIDESa Scientific, Inc.K920716DIRECT PREGNANCY TESTTech-Co, Inc.

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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