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)

PYLORITRAK

K-Number: K912215 · 1991-10-04

ApplicantBainbridge Laboratories, Inc.
Decision Date1991-10-04
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PYLORITRAK is the device name listed in this FDA 510(k) record. The listed applicant is Bainbridge Laboratories, Inc.. It received FDA 510(k) clearance on 1991-10-04 under 510(k) number K912215. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PYLORITRAK?

PYLORITRAK is a medical device that received FDA 510(k) clearance on 1991-10-04. The listed applicant is Bainbridge Laboratories, Inc.. The 510(k) number is K912215.

When did PYLORITRAK receive FDA 510(k) clearance?

PYLORITRAK received FDA 510(k) clearance on 1991-10-04, under 510(k) number K912215.

Who is the listed applicant for PYLORITRAK?

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

What is the FDA product code for PYLORITRAK?

The FDA product code for PYLORITRAK is LYR.

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 Bainbridge Laboratories, 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.

K880076G-MARK

Related Devices (Code: LYR)

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.

K232892Hp Detect™ Stool Antigen ELISABiomerica, Inc.K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc.K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc.K183573Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc.K182559PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc.K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, 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.

↑