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FDA 510(k)

BIOTIS TSA WITH 5% RABBIT BLOOD

K-Number: K860403 · 1986-02-24

ApplicantOtisville Biotech, Inc.
Decision Date1986-02-24
Product CodeJSG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOTIS TSA WITH 5% RABBIT BLOOD 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 1986-02-24 under 510(k) number K860403. 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 TSA WITH 5% RABBIT BLOOD?

BIOTIS TSA WITH 5% RABBIT BLOOD is a medical device that received FDA 510(k) clearance on 1986-02-24. The listed applicant is Otisville Biotech, Inc.. The 510(k) number is K860403.

When did BIOTIS TSA WITH 5% RABBIT BLOOD receive FDA 510(k) clearance?

BIOTIS TSA WITH 5% RABBIT BLOOD received FDA 510(k) clearance on 1986-02-24, under 510(k) number K860403.

Who is the listed applicant for BIOTIS TSA WITH 5% RABBIT BLOOD?

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 TSA WITH 5% RABBIT BLOOD?

The FDA product code for BIOTIS TSA WITH 5% RABBIT BLOOD 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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