FDA 510(k)

SMITH'S SYSTEMIC FUNGAL MEDIUM

K-Number: K812187 · 1981-08-31

Decision Date1981-08-31

Product CodeJSI

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SMITH'S SYSTEMIC FUNGAL MEDIUM 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 1981-08-31 under 510(k) number K812187. The device is classified under product code JSI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH'S SYSTEMIC FUNGAL MEDIUM?

SMITH'S SYSTEMIC FUNGAL MEDIUM is a medical device that received FDA 510(k) clearance on 1981-08-31. The listed applicant is American Scientific Products. The 510(k) number is K812187.

When did SMITH'S SYSTEMIC FUNGAL MEDIUM receive FDA 510(k) clearance?

SMITH'S SYSTEMIC FUNGAL MEDIUM received FDA 510(k) clearance on 1981-08-31, under 510(k) number K812187.

Who is the listed applicant for SMITH'S SYSTEMIC FUNGAL MEDIUM?

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 SMITH'S SYSTEMIC FUNGAL MEDIUM?

The FDA product code for SMITH'S SYSTEMIC FUNGAL MEDIUM is JSI.

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Related Devices (Code: JSI)

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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.