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FDA 510(k)

MODIFICATION OF EST CULTURE SYSTEM II - MYCO

K-Number: K972756 · 1997-08-01

ApplicantAccumed Intl., Inc.
Decision Date1997-08-01
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF EST CULTURE SYSTEM II - MYCO is the device name listed in this FDA 510(k) record. The listed applicant is Accumed Intl., Inc.. It received FDA 510(k) clearance on 1997-08-01 under 510(k) number K972756. 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 MODIFICATION OF EST CULTURE SYSTEM II - MYCO?

MODIFICATION OF EST CULTURE SYSTEM II - MYCO is a medical device that received FDA 510(k) clearance on 1997-08-01. The listed applicant is Accumed Intl., Inc.. The 510(k) number is K972756.

When did MODIFICATION OF EST CULTURE SYSTEM II - MYCO receive FDA 510(k) clearance?

MODIFICATION OF EST CULTURE SYSTEM II - MYCO received FDA 510(k) clearance on 1997-08-01, under 510(k) number K972756.

Who is the listed applicant for MODIFICATION OF EST CULTURE SYSTEM II - MYCO?

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

What is the FDA product code for MODIFICATION OF EST CULTURE SYSTEM II - MYCO?

The FDA product code for MODIFICATION OF EST CULTURE SYSTEM II - 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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