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FDA 510(k)

IMMUNO-CEPT D (BETA-MONOCLONAL)

K-Number: K863741 · 1986-11-13

ApplicantImmunostics Co., Inc.
Decision Date1986-11-13
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMUNO-CEPT D (BETA-MONOCLONAL) is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Co., Inc.. It received FDA 510(k) clearance on 1986-11-13 under 510(k) number K863741. 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 IMMUNO-CEPT D (BETA-MONOCLONAL)?

IMMUNO-CEPT D (BETA-MONOCLONAL) is a medical device that received FDA 510(k) clearance on 1986-11-13. The listed applicant is Immunostics Co., Inc.. The 510(k) number is K863741.

When did IMMUNO-CEPT D (BETA-MONOCLONAL) receive FDA 510(k) clearance?

IMMUNO-CEPT D (BETA-MONOCLONAL) received FDA 510(k) clearance on 1986-11-13, under 510(k) number K863741.

Who is the listed applicant for IMMUNO-CEPT D (BETA-MONOCLONAL)?

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

What is the FDA product code for IMMUNO-CEPT D (BETA-MONOCLONAL)?

The FDA product code for IMMUNO-CEPT D (BETA-MONOCLONAL) is JHJ.

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Other records listing Immunostics Co., 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.

K926569IMMUNO RA UNDILUTEDK902360HEMA-SCREENK894780IMMUNO/ASOK883685IMMUNO/FEBRILE ANTIGENSK872910IMMUNO/SLEK854619DETECTACULT

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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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