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)

KLEEN TEST O.R. KIT

K-Number: K890098 · 1989-01-24

ApplicantKleen Test Products
Decision Date1989-01-24
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KLEEN TEST O.R. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Kleen Test Products. It received FDA 510(k) clearance on 1989-01-24 under 510(k) number K890098. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLEEN TEST O.R. KIT?

KLEEN TEST O.R. KIT is a medical device that received FDA 510(k) clearance on 1989-01-24. The listed applicant is Kleen Test Products. The 510(k) number is K890098.

When did KLEEN TEST O.R. KIT receive FDA 510(k) clearance?

KLEEN TEST O.R. KIT received FDA 510(k) clearance on 1989-01-24, under 510(k) number K890098.

Who is the listed applicant for KLEEN TEST O.R. KIT?

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

What is the FDA product code for KLEEN TEST O.R. KIT?

The FDA product code for KLEEN TEST O.R. KIT is LRO.

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 Kleen Test Products 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.

K890039KLEEN TEST BASIN SETK890539SURE COUNT LIGHT HANDLE COVERK853622SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030K853454SURE COUNT 5 & 10 SPONGE COUNTERK853315CAUTERY TIP CLEANING PADK852258SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER

View all 17 devices →

Related Devices (Code: LRO)

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.

K213481Medline General Surgery TrayMedline Industries, Inc.K212258Medline Cardiovascular Procedure KitMedline Industries, Inc.K041080SURGICAL DRAPE KIT - D.I.R.R.A. SRLD.I.R.R.A. S.R.L.K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical ProductsK023276AMSINO TRACHEOSTOMY CARE TRAYAmsino International, Inc.K980137WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYWorldwide Medical Technologies, 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.

↑