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FDA 510(k)

HISTOPLASMA MYCELIAL ANTIGEN

K-Number: K760826 · 1976-11-01

ApplicantI M, Inc.
Decision Date1976-11-01
Product CodeGMJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HISTOPLASMA MYCELIAL ANTIGEN is the device name listed in this FDA 510(k) record. The listed applicant is I M, Inc.. It received FDA 510(k) clearance on 1976-11-01 under 510(k) number K760826. 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 HISTOPLASMA MYCELIAL ANTIGEN?

HISTOPLASMA MYCELIAL ANTIGEN is a medical device that received FDA 510(k) clearance on 1976-11-01. The listed applicant is I M, Inc.. The 510(k) number is K760826.

When did HISTOPLASMA MYCELIAL ANTIGEN receive FDA 510(k) clearance?

HISTOPLASMA MYCELIAL ANTIGEN received FDA 510(k) clearance on 1976-11-01, under 510(k) number K760826.

Who is the listed applicant for HISTOPLASMA MYCELIAL ANTIGEN?

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

What is the FDA product code for HISTOPLASMA MYCELIAL ANTIGEN?

The FDA product code for HISTOPLASMA MYCELIAL ANTIGEN is GMJ.

Related Clinical Trials

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Other records listing I M, 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.

K914600NEUROLOGICAL SPONGEK892389BIOPSY KITK881363SYRINGE PREFILLED WITH WATERK880753UMBILICAL CORD CLAMPK872741NUTRIPUMPK871495BANDAGES CATALOG NUMBER: 101 TO 220

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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 ProductsK802130IMMUNO. IDENTIFICATION OF H. CAPSULATUMNolan Biological Laboratories, Inc.K792701HISTOPLASMA CAPSULATUM, ANTIGENMeridian Diagnostics, Inc.K792704HISTOPLASMA CAPSULATUM, ANTIGEN YEASTMeridian Diagnostics, Inc.K792711HISTOPLASMA CAPSULATUM, ANTISERUMMeridian Diagnostics, 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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