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)

ALKALINE PHOSPHATASE LIQUID REAGENT

K-Number: K011599 · 2001-07-20

ApplicantJas Diagnostics, Inc.
Decision Date2001-07-20
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE LIQUID REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Jas Diagnostics, Inc.. It received FDA 510(k) clearance on 2001-07-20 under 510(k) number K011599. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALKALINE PHOSPHATASE LIQUID REAGENT?

ALKALINE PHOSPHATASE LIQUID REAGENT is a medical device that received FDA 510(k) clearance on 2001-07-20. The listed applicant is Jas Diagnostics, Inc.. The 510(k) number is K011599.

When did ALKALINE PHOSPHATASE LIQUID REAGENT receive FDA 510(k) clearance?

ALKALINE PHOSPHATASE LIQUID REAGENT received FDA 510(k) clearance on 2001-07-20, under 510(k) number K011599.

Who is the listed applicant for ALKALINE PHOSPHATASE LIQUID REAGENT?

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

What is the FDA product code for ALKALINE PHOSPHATASE LIQUID REAGENT?

The FDA product code for ALKALINE PHOSPHATASE LIQUID REAGENT is CJE.

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 Jas Diagnostics, 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.

K080623CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NAK080618DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUIDK022519LDL CHOLESTEROL (AUTOMATED)K021671JAS HDL CHOLESTEROL (AUTOMATED) REAGENTK020454CHEMISTRY CALIBRATORK020282JAS AMYLASE LIQUID REAGENT

View all 19 devices →

Related Devices (Code: CJE)

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.

K251074Tru Liver Health Test PanelTruvian HealthK240468Alkaline PhosphataseAbbott Laboratories Diagnostics DivisionK223317Alkaline Phosphatase2Abbott Ireland Diagnostics DivisionK191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHORIBA ABX SASK171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry AnalyzerLite-On Technology Corp. H.S.P.B.K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)

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.

↑