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)

CONTROL STRIP FOR VISUAL URINALYSIS

K-Number: K781961 · 1979-02-08

ApplicantMiles Laboratories, Inc.
Decision Date1979-02-08
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CONTROL STRIP FOR VISUAL URINALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1979-02-08 under 510(k) number K781961. 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 CONTROL STRIP FOR VISUAL URINALYSIS?

CONTROL STRIP FOR VISUAL URINALYSIS is a medical device that received FDA 510(k) clearance on 1979-02-08. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K781961.

When did CONTROL STRIP FOR VISUAL URINALYSIS receive FDA 510(k) clearance?

CONTROL STRIP FOR VISUAL URINALYSIS received FDA 510(k) clearance on 1979-02-08, under 510(k) number K781961.

Who is the listed applicant for CONTROL STRIP FOR VISUAL URINALYSIS?

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

What is the FDA product code for CONTROL STRIP FOR VISUAL URINALYSIS?

The FDA product code for CONTROL STRIP FOR VISUAL 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 Miles 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.

K880605LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTERK874909MICRO-BUMINTEST REAGENT TABLETSK875079MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULEK871835GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINTK872120SERALYZER III BLOOD CHEMISTRY ANALYZERK873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)

View all 158 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.

↑