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)

DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403)

K-Number: K864863 · 1987-01-13

ApplicantDynatech Laboratories, Inc.
Decision Date1987-01-13
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403) is the device name listed in this FDA 510(k) record. The listed applicant is Dynatech Laboratories, Inc.. It received FDA 510(k) clearance on 1987-01-13 under 510(k) number K864863. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403)?

DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403) is a medical device that received FDA 510(k) clearance on 1987-01-13. The listed applicant is Dynatech Laboratories, Inc.. The 510(k) number is K864863.

When did DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403) receive FDA 510(k) clearance?

DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403) received FDA 510(k) clearance on 1987-01-13, under 510(k) number K864863.

Who is the listed applicant for DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403)?

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

What is the FDA product code for DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403)?

The FDA product code for DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403) is JKA.

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 Dynatech 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.

K962265MLX MICROTITER PLATE LUMINOMETERK934111MR7000 WITH TIME MANAGER SOFTWARE (TMS)K943701MRX MICROPLATE READERK923456MICROLITE MICROTITER PLATE LUMINOMETER ML3000K915896MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODIK920888MICROLITE MICROTITER PLATE LUMINOMETER ML2200

View all 44 devices →

Related Devices (Code: JKA)

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.

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and CompanyK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and CompanyK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and CompanyK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company

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.

↑