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FDA 510(k)

BIOTIS TODD HEWITT BROTH

K-Number: K860399 · 1986-02-24

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

Device Summary

BIOTIS TODD HEWITT 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 1986-02-24 under 510(k) number K860399. 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 TODD HEWITT BROTH?

BIOTIS TODD HEWITT BROTH 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 K860399.

When did BIOTIS TODD HEWITT BROTH receive FDA 510(k) clearance?

BIOTIS TODD HEWITT BROTH received FDA 510(k) clearance on 1986-02-24, under 510(k) number K860399.

Who is the listed applicant for BIOTIS TODD HEWITT 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 TODD HEWITT BROTH?

The FDA product code for BIOTIS TODD HEWITT 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.

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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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