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FDA 510(k)

BIOTIS MOTILITY TEST MEDIUM

K-Number: K862392 · 1986-07-03

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

Device Summary

BIOTIS MOTILITY TEST MEDIUM 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 K862392. 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 MOTILITY TEST MEDIUM?

BIOTIS MOTILITY TEST MEDIUM 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 K862392.

When did BIOTIS MOTILITY TEST MEDIUM receive FDA 510(k) clearance?

BIOTIS MOTILITY TEST MEDIUM received FDA 510(k) clearance on 1986-07-03, under 510(k) number K862392.

Who is the listed applicant for BIOTIS MOTILITY TEST MEDIUM?

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 MOTILITY TEST MEDIUM?

The FDA product code for BIOTIS MOTILITY TEST MEDIUM 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.

K862397BIOTIS DECARBOXYLASE MEDIA, LYSINEK862393BIOTIS 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 MediaK880119MOELLERS DECARBOXYLASE, ONITHINEHardy MediaK880120MOELLERS DECARBOXYLASE, LYSINEHardy 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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