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)

ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS

K-Number: K000556 · 2000-05-17

ApplicantElan Diagnostics
Decision Date2000-05-17
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS is the device name listed in this FDA 510(k) record. The listed applicant is Elan Diagnostics. It received FDA 510(k) clearance on 2000-05-17 under 510(k) number K000556. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS?

ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS is a medical device that received FDA 510(k) clearance on 2000-05-17. The listed applicant is Elan Diagnostics. The 510(k) number is K000556.

When did ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS receive FDA 510(k) clearance?

ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS received FDA 510(k) clearance on 2000-05-17, under 510(k) number K000556.

Who is the listed applicant for ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS?

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

What is the FDA product code for ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS?

The FDA product code for ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS is CFR.

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 Elan Diagnostics 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.

K030003ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATORK030014ATAC TOTAL BILIRUBIN REAGENTK030621ATAC CALIBRATORK023105ATAC CALCIUM REAGENT AND ATAC CALIBRATORK030010ATAC PAK MAGNESIUM REAGENTK030006ATAC PAK ALBUMIN REAGENT

View all 13 devices →

Related Devices (Code: CFR)

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.

K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche DiagnosticsK252357Glucose2Abbott IrelandK220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche DiagnosticsK191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche DiagnosticsK170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott LaboratoriesK153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIElitechgroup

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.

↑