Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BIOTIS (TM) SABHI (DOUBLE POUR)

K-Number: K874179 · 1988-01-28

ApplicantOtisville Biopharm, Inc.
Decision Date1988-01-28
Product CodeKZI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOTIS (TM) SABHI (DOUBLE POUR) is the device name listed in this FDA 510(k) record. The listed applicant is Otisville Biopharm, Inc.. It received FDA 510(k) clearance on 1988-01-28 under 510(k) number K874179. The device is classified under product code KZI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTIS (TM) SABHI (DOUBLE POUR)?

BIOTIS (TM) SABHI (DOUBLE POUR) is a medical device that received FDA 510(k) clearance on 1988-01-28. The listed applicant is Otisville Biopharm, Inc.. The 510(k) number is K874179.

When did BIOTIS (TM) SABHI (DOUBLE POUR) receive FDA 510(k) clearance?

BIOTIS (TM) SABHI (DOUBLE POUR) received FDA 510(k) clearance on 1988-01-28, under 510(k) number K874179.

Who is the listed applicant for BIOTIS (TM) SABHI (DOUBLE POUR)?

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

What is the FDA product code for BIOTIS (TM) SABHI (DOUBLE POUR)?

The FDA product code for BIOTIS (TM) SABHI (DOUBLE POUR) is KZI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Otisville Biopharm, 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.

K874176BIOTIS (TM) HAEMOPHILUS DUCREYIK874177BIOTIS (TM) BCYEK874175BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXACK874178BIOTIS (TM) BCYE SELECTIVEK874174BIOTIS (TM) STARCH HYDROLYSIS WITH BCPK874172BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR)

View all 8 devices →

Related Devices (Code: KZI)

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.

K884208LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)Oxoid U.S.A., Inc.K881995DIAMOND'S MEDIUM MODIFIEDRemel Co.K880131LOWENSTEIN-JENSEN, GRUFTHardy MediaK880122MIDDLEBROOK 7H9 BROTHHardy MediaK880134MIDDLEBROOK 7H11 AGARHardy MediaK880138WALLENSTEIN MEDIUM SLANTHardy 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.

↑