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FDA 510(k)

BIOTIS DECARBOXYLASE MEDIA, LYSINE

K-Number: K862397 · 1986-07-03

ApplicantOtisville Biotech, Inc.
Decision Date1986-07-03
Product CodeJSF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOTIS DECARBOXYLASE MEDIA, LYSINE is the device name listed in this FDA 510(k) record. The listed applicant is Otisville Biotech, Inc.. It received FDA 510(k) clearance on 1986-07-03 under 510(k) number K862397. 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 BIOTIS DECARBOXYLASE MEDIA, LYSINE?

BIOTIS DECARBOXYLASE MEDIA, LYSINE is a medical device that received FDA 510(k) clearance on 1986-07-03. The listed applicant is Otisville Biotech, Inc.. The 510(k) number is K862397.

When did BIOTIS DECARBOXYLASE MEDIA, LYSINE receive FDA 510(k) clearance?

BIOTIS DECARBOXYLASE MEDIA, LYSINE received FDA 510(k) clearance on 1986-07-03, under 510(k) number K862397.

Who is the listed applicant for BIOTIS DECARBOXYLASE MEDIA, LYSINE?

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

What is the FDA product code for BIOTIS DECARBOXYLASE MEDIA, LYSINE?

The FDA product code for BIOTIS DECARBOXYLASE MEDIA, LYSINE is JSF.

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Other records listing Otisville Biotech, Inc. 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.

K862392BIOTIS MOTILITY TEST MEDIUMK862393BIOTIS LITMUS MILKK862398BIOTIS DECARBOXYLASE MEDIA, ORNITHINEK862390BIOTIS BORDET GENGOU AGARK862388BIOTIS TCBS AGARK862391BIOTIS DESOXYCHOLATE AGAR

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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 MediaK880119MOELLERS DECARBOXYLASE, ONITHINEHardy MediaK880139ONPG TEST REAGENTHardy MediaK880113CYSTINE TRYPTIC MEDIUM W/LACTOSEHardy 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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