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FDA 510(k)

B-CLONE HCG ASSAY

K-Number: K831155 · 1983-06-02

ApplicantMonoclonal Antibodies, Inc.
Decision Date1983-06-02
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

B-CLONE 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 1983-06-02 under 510(k) number K831155. 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 B-CLONE HCG ASSAY?

B-CLONE HCG ASSAY is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is Monoclonal Antibodies, Inc.. The 510(k) number is K831155.

When did B-CLONE HCG ASSAY receive FDA 510(k) clearance?

B-CLONE HCG ASSAY received FDA 510(k) clearance on 1983-06-02, under 510(k) number K831155.

Who is the listed applicant for B-CLONE 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 B-CLONE HCG ASSAY?

The FDA product code for B-CLONE 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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