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)

IRISPEC,CA/CB/CC

K-Number: K072640 · 2007-12-21

ApplicantIris Diagnostics
Decision Date2007-12-21
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRISPEC,CA/CB/CC is the device name listed in this FDA 510(k) record. The listed applicant is Iris Diagnostics. It received FDA 510(k) clearance on 2007-12-21 under 510(k) number K072640. 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 IRISPEC,CA/CB/CC?

IRISPEC,CA/CB/CC is a medical device that received FDA 510(k) clearance on 2007-12-21. The listed applicant is Iris Diagnostics. The 510(k) number is K072640.

When did IRISPEC,CA/CB/CC receive FDA 510(k) clearance?

IRISPEC,CA/CB/CC received FDA 510(k) clearance on 2007-12-21, under 510(k) number K072640.

Who is the listed applicant for IRISPEC,CA/CB/CC?

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

What is the FDA product code for IRISPEC,CA/CB/CC?

The FDA product code for IRISPEC,CA/CB/CC 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 Iris Diagnostics 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.

K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULE

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 CorporationK070848LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435XBio-Rad, Diagnostics Grp.K052242ADVIA CHEMISTRY MICROALBUMIN CONTROLSBayer Healthcare, 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.

↑