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FDA 510(k)

BIOTIS SCHAEDLER AGAR & BROTH

K-Number: K843764 · 1984-10-10

ApplicantOtisville Biotech, Inc.
Decision Date1984-10-10
Product CodeJSG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOTIS SCHAEDLER AGAR & BROTH 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 1984-10-10 under 510(k) number K843764. The device is classified under product code JSG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTIS SCHAEDLER AGAR & BROTH?

BIOTIS SCHAEDLER AGAR & BROTH is a medical device that received FDA 510(k) clearance on 1984-10-10. The listed applicant is Otisville Biotech, Inc.. The 510(k) number is K843764.

When did BIOTIS SCHAEDLER AGAR & BROTH receive FDA 510(k) clearance?

BIOTIS SCHAEDLER AGAR & BROTH received FDA 510(k) clearance on 1984-10-10, under 510(k) number K843764.

Who is the listed applicant for BIOTIS SCHAEDLER AGAR & BROTH?

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 SCHAEDLER AGAR & BROTH?

The FDA product code for BIOTIS SCHAEDLER AGAR & BROTH is JSG.

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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.

K862397BIOTIS DECARBOXYLASE MEDIA, LYSINEK862393BIOTIS LITMUS MILKK862398BIOTIS DECARBOXYLASE MEDIA, ORNITHINEK862390BIOTIS BORDET GENGOU AGARK862388BIOTIS TCBS AGARK862392BIOTIS MOTILITY TEST MEDIUM

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Related Devices (Code: JSG)

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.

K882495THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007Lakewood Biochemical Co., Inc.K881558TRYPTOSE AGARAcumedia Manufacturers, Inc.K881550OF BASAL MEDIUMAcumedia Manufacturers, Inc.K881557TRYPTONEAcumedia Manufacturers, Inc.K881564TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACTAcumedia Manufacturers, Inc.K881533BLOOD AGAR BASE NO. 2Acumedia Manufacturers, Inc.

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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