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)

ETOH FLEX REAGENT CARTRIDGE (DF22)

K-Number: K071811 · 2007-08-24

ApplicantDade Behring, Inc.
Decision Date2007-08-24
Product CodeDIC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ETOH FLEX REAGENT CARTRIDGE (DF22) is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2007-08-24 under 510(k) number K071811. The device is classified under product code DIC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETOH FLEX REAGENT CARTRIDGE (DF22)?

ETOH FLEX REAGENT CARTRIDGE (DF22) is a medical device that received FDA 510(k) clearance on 2007-08-24. The listed applicant is Dade Behring, Inc.. The 510(k) number is K071811.

When did ETOH FLEX REAGENT CARTRIDGE (DF22) receive FDA 510(k) clearance?

ETOH FLEX REAGENT CARTRIDGE (DF22) received FDA 510(k) clearance on 2007-08-24, under 510(k) number K071811.

Who is the listed applicant for ETOH FLEX REAGENT CARTRIDGE (DF22)?

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

What is the FDA product code for ETOH FLEX REAGENT CARTRIDGE (DF22)?

The FDA product code for ETOH FLEX REAGENT CARTRIDGE (DF22) is DIC.

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 Dade Behring, 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.

K093848PT-MULTI-CALIBRATOR, MODEL OPAT07K081161DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYSTK081249DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEMK071603DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)K071597DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600K073604DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

View all 343 devices →

Related Devices (Code: DIC)

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.

K250609Sober Self-TestSober Ip, LLCK181553Immunalysis Ethyl Alcohol Enzyme AssayImmunalysis CorporationK121247ALCO-SCREENChematics, Inc.K121256ALCO-SCREEN 02Chematics, Inc.K111005ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIALMedica Corp.K111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTTeco Diagnostics

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.

↑