FDA 510(k)

TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL

K-Number: K954322 · 1995-10-11

Decision Date1995-10-11

Product CodeDIF

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL 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 1995-10-11 under 510(k) number K954322. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL?

TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL is a medical device that received FDA 510(k) clearance on 1995-10-11. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K954322.

When did TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL receive FDA 510(k) clearance?

TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL received FDA 510(k) clearance on 1995-10-11, under 510(k) number K954322.

Who is the listed applicant for TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL?

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 TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL?

The FDA product code for TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL is DIF.

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: DIF)

K153474Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm seriesBiochemical Diagnostics, Inc.K132688SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZBiochemical Diagnostics, Inc.K132174MULTICHEM WBTTechno-Path Manufacturing , Ltd.K121122DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROLBiochemical Diagnostic, Inc.K121143LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)Bio-Rad Laboratories K120504LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAKBio-Rad Laboratories, 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.