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FDA 510(k)

MOELLERS DECARBOXYLASE, ONITHINE

K-Number: K880119 · 1988-03-31

ApplicantHardy Media
Decision Date1988-03-31
Product CodeJSF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MOELLERS DECARBOXYLASE, ONITHINE is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Media. It received FDA 510(k) clearance on 1988-03-31 under 510(k) number K880119. The device is classified under product code JSF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOELLERS DECARBOXYLASE, ONITHINE?

MOELLERS DECARBOXYLASE, ONITHINE is a medical device that received FDA 510(k) clearance on 1988-03-31. The listed applicant is Hardy Media. The 510(k) number is K880119.

When did MOELLERS DECARBOXYLASE, ONITHINE receive FDA 510(k) clearance?

MOELLERS DECARBOXYLASE, ONITHINE received FDA 510(k) clearance on 1988-03-31, under 510(k) number K880119.

Who is the listed applicant for MOELLERS DECARBOXYLASE, ONITHINE?

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

What is the FDA product code for MOELLERS DECARBOXYLASE, ONITHINE?

The FDA product code for MOELLERS DECARBOXYLASE, ONITHINE is JSF.

Related Clinical Trials

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.

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Other records listing Hardy Media 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.

K880134MIDDLEBROOK 7H11 AGARK880122MIDDLEBROOK 7H9 BROTHK880131LOWENSTEIN-JENSEN, GRUFTK880133MIL MEDIUMK880126LAURYL TRYPTOSE BROTHK880116MRVP BROTH

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Related Devices (Code: JSF)

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.

K880946NUTRIENT GELATIN - PRODUCT NUMBER T2860Lakewood Biochemical Co., Inc.K880126LAURYL TRYPTOSE BROTHHardy MediaK880120MOELLERS DECARBOXYLASE, LYSINEHardy MediaK880139ONPG TEST REAGENTHardy MediaK880113CYSTINE TRYPTIC MEDIUM W/LACTOSEHardy MediaK880135NITRATE BROTHHardy Media

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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