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FDA 510(k)

IMMUNO. IDENTIFICATION OF H. CAPSULATUM

K-Number: K802130 · 1980-09-26

ApplicantNolan Biological Laboratories, Inc.
Decision Date1980-09-26
Product CodeGMJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNO. IDENTIFICATION OF H. CAPSULATUM is the device name listed in this FDA 510(k) record. The listed applicant is Nolan Biological Laboratories, Inc.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K802130. The device is classified under product code GMJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNO. IDENTIFICATION OF H. CAPSULATUM?

IMMUNO. IDENTIFICATION OF H. CAPSULATUM is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Nolan Biological Laboratories, Inc.. The 510(k) number is K802130.

When did IMMUNO. IDENTIFICATION OF H. CAPSULATUM receive FDA 510(k) clearance?

IMMUNO. IDENTIFICATION OF H. CAPSULATUM received FDA 510(k) clearance on 1980-09-26, under 510(k) number K802130.

Who is the listed applicant for IMMUNO. IDENTIFICATION OF H. CAPSULATUM?

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

What is the FDA product code for IMMUNO. IDENTIFICATION OF H. CAPSULATUM?

The FDA product code for IMMUNO. IDENTIFICATION OF H. CAPSULATUM is GMJ.

Related Clinical Trials

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Other records listing Nolan Biological Laboratories, 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.

K812741REAGENTS FOR SERODIAGNOSIS OF CANDIDOSISK812740REAGENTS FOR SERODIAGNOSIS OF ASPERGILLK802129IMMUNODIFFUSION REAGENTS/SEROLOGICALK802128IMMUNODIFFUSSION REAGENTS/SEROLOGICAL

Related Devices (Code: GMJ)

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.

K830837LA-HISTO ANTIBODY SYSTEM #HL 1001Immuno-Mycologics, Inc.K813359MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGLAmerican Scientific ProductsK792701HISTOPLASMA CAPSULATUM, ANTIGENMeridian Diagnostics, Inc.K792711HISTOPLASMA CAPSULATUM, ANTISERUMMeridian Diagnostics, Inc.K792704HISTOPLASMA CAPSULATUM, ANTIGEN YEASTMeridian Diagnostics, Inc.K792708HISTOPLASMA CAPSULATUM, MYCELIAL PHASEMeridian Diagnostics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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