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)

HELENA COLOSCREEN METHOD

K-Number: K812428 · 1981-10-23

ApplicantHelena Laboratories
Decision Date1981-10-23
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HELENA COLOSCREEN METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1981-10-23 under 510(k) number K812428. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELENA COLOSCREEN METHOD?

HELENA COLOSCREEN METHOD is a medical device that received FDA 510(k) clearance on 1981-10-23. The listed applicant is Helena Laboratories. The 510(k) number is K812428.

When did HELENA COLOSCREEN METHOD receive FDA 510(k) clearance?

HELENA COLOSCREEN METHOD received FDA 510(k) clearance on 1981-10-23, under 510(k) number K812428.

Who is the listed applicant for HELENA COLOSCREEN METHOD?

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

What is the FDA product code for HELENA COLOSCREEN METHOD?

The FDA product code for HELENA COLOSCREEN METHOD is KHE.

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 Helena Laboratories 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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

View all 280 devices →

Related Devices (Code: KHE)

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.

K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc.K170548InSure ONEEnterix, Inc.K171484hema-screen SPECIFIC GoldImmunostics Inc.,K162333Wondfo One Step Fecal Occult Blood (FOB) TestGuangzhou Wondfo Biotech Co., Ltd.K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestImmunostics Inc.,K121397OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KITSEKISUI Diagnostics, LLC

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.

↑