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FDA 510(k)

ESP CULTURE SYSTEM - MYCO

K-Number: K953129 · 1995-12-26

ApplicantDifco Laboratories, Inc.
Decision Date1995-12-26
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ESP CULTURE SYSTEM - MYCO is the device name listed in this FDA 510(k) record. The listed applicant is Difco Laboratories, Inc.. It received FDA 510(k) clearance on 1995-12-26 under 510(k) number K953129. The device is classified under product code MDB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESP CULTURE SYSTEM - MYCO?

ESP CULTURE SYSTEM - MYCO is a medical device that received FDA 510(k) clearance on 1995-12-26. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K953129.

When did ESP CULTURE SYSTEM - MYCO receive FDA 510(k) clearance?

ESP CULTURE SYSTEM - MYCO received FDA 510(k) clearance on 1995-12-26, under 510(k) number K953129.

Who is the listed applicant for ESP CULTURE SYSTEM - MYCO?

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

What is the FDA product code for ESP CULTURE SYSTEM - MYCO?

The FDA product code for ESP CULTURE SYSTEM - MYCO is MDB.

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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.

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