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FDA 510(k)

LA-HISTO ANTIBODY SYSTEM #HL 1001

K-Number: K830837 · 1983-05-05

ApplicantImmuno-Mycologics, Inc.
Decision Date1983-05-05
Product CodeGMJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LA-HISTO ANTIBODY SYSTEM #HL 1001 is the device name listed in this FDA 510(k) record. The listed applicant is Immuno-Mycologics, Inc.. It received FDA 510(k) clearance on 1983-05-05 under 510(k) number K830837. 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 LA-HISTO ANTIBODY SYSTEM #HL 1001?

LA-HISTO ANTIBODY SYSTEM #HL 1001 is a medical device that received FDA 510(k) clearance on 1983-05-05. The listed applicant is Immuno-Mycologics, Inc.. The 510(k) number is K830837.

When did LA-HISTO ANTIBODY SYSTEM #HL 1001 receive FDA 510(k) clearance?

LA-HISTO ANTIBODY SYSTEM #HL 1001 received FDA 510(k) clearance on 1983-05-05, under 510(k) number K830837.

Who is the listed applicant for LA-HISTO ANTIBODY SYSTEM #HL 1001?

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

What is the FDA product code for LA-HISTO ANTIBODY SYSTEM #HL 1001?

The FDA product code for LA-HISTO ANTIBODY SYSTEM #HL 1001 is GMJ.

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Other records listing Immuno-Mycologics, Inc. as applicant

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K120946ALPHA CRYPTOCOCCAL ANTIGEN EIAK112422CRAG LATERAL FLOW ASSAY (LFA)K102286CRAG LATERAL FLOW ASSAY (CRAG LFA)K101407ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102K883333RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENTK880029EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001

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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.

K813359MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGLAmerican Scientific ProductsK802130IMMUNO. 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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