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)

MLX MICROTITER PLATE LUMINOMETER

K-Number: K962265 · 1996-07-25

ApplicantDynatech Laboratories, Inc.
Decision Date1996-07-25
Product CodeJSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MLX MICROTITER PLATE LUMINOMETER 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 1996-07-25 under 510(k) number K962265. The device is classified under product code JSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MLX MICROTITER PLATE LUMINOMETER?

MLX MICROTITER PLATE LUMINOMETER is a medical device that received FDA 510(k) clearance on 1996-07-25. The listed applicant is Dynatech Laboratories, Inc.. The 510(k) number is K962265.

When did MLX MICROTITER PLATE LUMINOMETER receive FDA 510(k) clearance?

MLX MICROTITER PLATE LUMINOMETER received FDA 510(k) clearance on 1996-07-25, under 510(k) number K962265.

Who is the listed applicant for MLX MICROTITER PLATE LUMINOMETER?

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 MLX MICROTITER PLATE LUMINOMETER?

The FDA product code for MLX MICROTITER PLATE LUMINOMETER is JSE.

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.

K934111MR7000 WITH TIME MANAGER SOFTWARE (TMS)K943701MRX MICROPLATE READERK923456MICROLITE MICROTITER PLATE LUMINOMETER ML3000K915896MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODIK920888MICROLITE MICROTITER PLATE LUMINOMETER ML2200K913590MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER

View all 44 devices →

Related Devices (Code: JSE)

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.

K883995X-ACT UREA/TDAPro-Lab, Inc.K883996X-ACT LDC/INDPro-Lab, Inc.K880133MIL MEDIUMHardy MediaK880116MRVP BROTHHardy MediaK874537KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGARLakewood Biochemical Co., Inc.K871096CYSTINE TRYPTIC AGAR W/O CARBOHYDRATESbioMerieux, Inc.

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.

↑