FDA 510(k)

TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III

K-Number: K904141 · 1990-11-01

Decision Date1990-11-01

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1990-11-01 under 510(k) number K904141. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III?

TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III is a medical device that received FDA 510(k) clearance on 1990-11-01. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K904141.

When did TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III receive FDA 510(k) clearance?

TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III received FDA 510(k) clearance on 1990-11-01, under 510(k) number K904141.

Who is the listed applicant for TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III?

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

What is the FDA product code for TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III?

The FDA product code for TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III is JJY.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medical Analysis Systems, Inc. as applicant

K042717MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL K041194ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H K040880MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 K032826MAS PAR TDM K032335MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL K031890MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

View all 107 devices →

Related Devices (Code: JJY)

K162530Multichem IA PlusTechno-Path Manufacturing K163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad Laboratories K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad Laboratories K132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

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.