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FDA 510(k)

FUNGAL IMMUNODIFFUSION SYSTEM

K-Number: K812185 · 1981-08-25

ApplicantAmerican Scientific Products
Decision Date1981-08-25
Product CodeGMI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FUNGAL IMMUNODIFFUSION SYSTEM 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 1981-08-25 under 510(k) number K812185. The device is classified under product code GMI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUNGAL IMMUNODIFFUSION SYSTEM?

FUNGAL IMMUNODIFFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1981-08-25. The listed applicant is American Scientific Products. The 510(k) number is K812185.

When did FUNGAL IMMUNODIFFUSION SYSTEM receive FDA 510(k) clearance?

FUNGAL IMMUNODIFFUSION SYSTEM received FDA 510(k) clearance on 1981-08-25, under 510(k) number K812185.

Who is the listed applicant for FUNGAL IMMUNODIFFUSION SYSTEM?

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 FUNGAL IMMUNODIFFUSION SYSTEM?

The FDA product code for FUNGAL IMMUNODIFFUSION SYSTEM is GMI.

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Other records listing American Scientific Products 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.

K864824INFECTIOUS TISSUE KITK844042BLOOD DILUTION VIALK831634GLUCOSE REAGENT B6360-11K831625UREA NITROGEN-BUN-REAGENTS B6360-12K831626UREA NITROGEN-BUN-REAGENTS B6370-11AK831628CREATININE REAGENTS B6370-13

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Related Devices (Code: GMI)

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.

K894617OLYMPUS PK-TP SYSTEM REACTIVE CONTROLSchiff & Co.K812190COCCIDIOIDES IMMUNODIFFUSION SYSTEMAmerican Scientific ProductsK802129IMMUNODIFFUSION REAGENTS/SEROLOGICALNolan Biological Laboratories, Inc.K792716CANDIDA ALBICANS, ANTIGENMeridian Diagnostics, Inc.K792713CANDIDA ALBICANS, ANTISERUMMeridian Diagnostics, Inc.K792682COCCIDIOIDES IMMITIS, ANTIGENMeridian 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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