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FDA 510(k)

STARCH HYDROLYSIS AGAR W/INDICATOR

K-Number: K844516 · 1985-01-07

ApplicantbioMerieux, Inc.
Decision Date1985-01-07
Product CodeJSH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STARCH HYDROLYSIS AGAR W/INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 1985-01-07 under 510(k) number K844516. The device is classified under product code JSH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STARCH HYDROLYSIS AGAR W/INDICATOR?

STARCH HYDROLYSIS AGAR W/INDICATOR is a medical device that received FDA 510(k) clearance on 1985-01-07. The listed applicant is bioMerieux, Inc.. The 510(k) number is K844516.

When did STARCH HYDROLYSIS AGAR W/INDICATOR receive FDA 510(k) clearance?

STARCH HYDROLYSIS AGAR W/INDICATOR received FDA 510(k) clearance on 1985-01-07, under 510(k) number K844516.

Who is the listed applicant for STARCH HYDROLYSIS AGAR W/INDICATOR?

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

What is the FDA product code for STARCH HYDROLYSIS AGAR W/INDICATOR?

The FDA product code for STARCH HYDROLYSIS AGAR W/INDICATOR is JSH.

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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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