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)

VITALAB AMYLASE REAGENT

K-Number: K040534 · 2004-03-11

ApplicantClinical Data, Inc.
Decision Date2004-03-11
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITALAB AMYLASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Data, Inc.. It received FDA 510(k) clearance on 2004-03-11 under 510(k) number K040534. The device is classified under product code JFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALAB AMYLASE REAGENT?

VITALAB AMYLASE REAGENT is a medical device that received FDA 510(k) clearance on 2004-03-11. The listed applicant is Clinical Data, Inc.. The 510(k) number is K040534.

When did VITALAB AMYLASE REAGENT receive FDA 510(k) clearance?

VITALAB AMYLASE REAGENT received FDA 510(k) clearance on 2004-03-11, under 510(k) number K040534.

Who is the listed applicant for VITALAB AMYLASE REAGENT?

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

What is the FDA product code for VITALAB AMYLASE REAGENT?

The FDA product code for VITALAB AMYLASE REAGENT is JFJ.

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 Clinical Data, 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.

K071706ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)K052591NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KITK033983VITALAB IRON REAGENTK040631VITALAB DIRECT BILIRUBIN REAGENTK034000VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATORK040508VITALAB MAGNESIUM REAGENT

View all 36 devices →

Related Devices (Code: JFJ)

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.

K210633Amylase2Abbott Ireland Diagnostics DivisionK191454Atellica CH Amylase_2 (AMY_2)Siemens Healthcare Diagnostics, Inc.K182474alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTALBiosystems S.A.K130685HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMYHitachi Chemical Diagnostics, Inc.K122858ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL IIElitechgroupK091846SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607Beckman Coulter, 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.

↑