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FDA 510(k)

MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL

K-Number: K813359 · 1981-12-31

ApplicantAmerican Scientific Products
Decision Date1981-12-31
Product CodeGMJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL is the device name listed in this FDA 510(k) record. The listed applicant is American Scientific Products. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813359. 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 MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL?

MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is American Scientific Products. The 510(k) number is K813359.

When did MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL receive FDA 510(k) clearance?

MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813359.

Who is the listed applicant for MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL?

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

What is the FDA product code for MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL?

The FDA product code for MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL is GMJ.

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Other records listing American Scientific Products as applicant

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K864824INFECTIOUS TISSUE KITK844042BLOOD DILUTION VIALK831634GLUCOSE REAGENT B6360-11K831626UREA NITROGEN-BUN-REAGENTS B6370-11AK831625UREA NITROGEN-BUN-REAGENTS B6360-12K831628CREATININE REAGENTS B6370-13

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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.K802130IMMUNO. IDENTIFICATION OF H. CAPSULATUMNolan Biological Laboratories, Inc.K792701HISTOPLASMA CAPSULATUM, ANTIGENMeridian Diagnostics, Inc.K792711HISTOPLASMA CAPSULATUM, ANTISERUMMeridian Diagnostics, Inc.K792704HISTOPLASMA CAPSULATUM, ANTIGEN YEASTMeridian Diagnostics, Inc.K792708HISTOPLASMA CAPSULATUM, MYCELIAL PHASEMeridian 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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