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)

CHEK-STIX CONTROL STRIPS FOR URINALYSIS

K-Number: K931467 · 1993-05-11

ApplicantHeraeus Kulzer, Inc.
Decision Date1993-05-11
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEK-STIX CONTROL STRIPS FOR URINALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1993-05-11 under 510(k) number K931467. The device is classified under product code JJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEK-STIX CONTROL STRIPS FOR URINALYSIS?

CHEK-STIX CONTROL STRIPS FOR URINALYSIS is a medical device that received FDA 510(k) clearance on 1993-05-11. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K931467.

When did CHEK-STIX CONTROL STRIPS FOR URINALYSIS receive FDA 510(k) clearance?

CHEK-STIX CONTROL STRIPS FOR URINALYSIS received FDA 510(k) clearance on 1993-05-11, under 510(k) number K931467.

Who is the listed applicant for CHEK-STIX CONTROL STRIPS FOR URINALYSIS?

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

What is the FDA product code for CHEK-STIX CONTROL STRIPS FOR URINALYSIS?

The FDA product code for CHEK-STIX CONTROL STRIPS FOR URINALYSIS is JJW.

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 Heraeus Kulzer, 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

View all 145 devices →

Related Devices (Code: JJW)

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.

K170091UA-Cellular CompleteStreckK110846RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2Randox Laboratories LimitedK103387MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROLACON Laboratories, Inc.K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2Cliniqa CorporationK072640IRISPEC,CA/CB/CCIris DiagnosticsK070848LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435XBio-Rad, Diagnostics Grp.

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.

↑