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FDA 510(k)

STANBIO QUICK-TELL MONOCLONAL INDIRECT

K-Number: K842544 · 1984-09-21

ApplicantStanbio Laboratory
Decision Date1984-09-21
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STANBIO QUICK-TELL MONOCLONAL INDIRECT is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1984-09-21 under 510(k) number K842544. 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 STANBIO QUICK-TELL MONOCLONAL INDIRECT?

STANBIO QUICK-TELL MONOCLONAL INDIRECT is a medical device that received FDA 510(k) clearance on 1984-09-21. The listed applicant is Stanbio Laboratory. The 510(k) number is K842544.

When did STANBIO QUICK-TELL MONOCLONAL INDIRECT receive FDA 510(k) clearance?

STANBIO QUICK-TELL MONOCLONAL INDIRECT received FDA 510(k) clearance on 1984-09-21, under 510(k) number K842544.

Who is the listed applicant for STANBIO QUICK-TELL MONOCLONAL INDIRECT?

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

What is the FDA product code for STANBIO QUICK-TELL MONOCLONAL INDIRECT?

The FDA product code for STANBIO QUICK-TELL MONOCLONAL INDIRECT is JHJ.

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Other records listing Stanbio Laboratory 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.

K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMK081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMK050283CREATININE LIQUICOLORK050266DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORK042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERK041155WIDE RANGE C-REACTIVE PROTEIN (WR CRP) 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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