FDA 510(k)

SELENITE CYSTINE BROTH

K-Number: K832533 · 1983-10-04

Decision Date1983-10-04

Product CodeKZI

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SELENITE CYSTINE 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 1983-10-04 under 510(k) number K832533. 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 SELENITE CYSTINE BROTH?

SELENITE CYSTINE BROTH is a medical device that received FDA 510(k) clearance on 1983-10-04. The listed applicant is Otisville Biotech, Inc.. The 510(k) number is K832533.

When did SELENITE CYSTINE BROTH receive FDA 510(k) clearance?

SELENITE CYSTINE BROTH received FDA 510(k) clearance on 1983-10-04, under 510(k) number K832533.

Who is the listed applicant for SELENITE CYSTINE 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 SELENITE CYSTINE BROTH?

The FDA product code for SELENITE CYSTINE BROTH 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Otisville Biotech, Inc. as applicant

K862397BIOTIS DECARBOXYLASE MEDIA, LYSINE K862393BIOTIS LITMUS MILK K862398BIOTIS DECARBOXYLASE MEDIA, ORNITHINE K862390BIOTIS BORDET GENGOU AGAR K862388BIOTIS TCBS AGAR K862392BIOTIS MOTILITY TEST MEDIUM

View all 98 devices →

Related Devices (Code: KZI)

K884208LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)Oxoid U.S.A., Inc.K881995DIAMOND'S MEDIUM MODIFIEDRemel Co.K880122MIDDLEBROOK 7H9 BROTHHardy Media K880131LOWENSTEIN-JENSEN, GRUFTHardy Media K880134MIDDLEBROOK 7H11 AGARHardy Media K880138WALLENSTEIN 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.