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)

GLUCOSE ASSAY KIT-HEXOKINASE

K-Number: K842510 · 1984-07-20

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1984-07-20
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE ASSAY KIT-HEXOKINASE is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1984-07-20 under 510(k) number K842510. 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 GLUCOSE ASSAY KIT-HEXOKINASE?

GLUCOSE ASSAY KIT-HEXOKINASE is a medical device that received FDA 510(k) clearance on 1984-07-20. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K842510.

When did GLUCOSE ASSAY KIT-HEXOKINASE receive FDA 510(k) clearance?

GLUCOSE ASSAY KIT-HEXOKINASE received FDA 510(k) clearance on 1984-07-20, under 510(k) number K842510.

Who is the listed applicant for GLUCOSE ASSAY KIT-HEXOKINASE?

The FDA 510(k) record lists Diagnostic Chemicals, Ltd. (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCOSE ASSAY KIT-HEXOKINASE?

The FDA product code for GLUCOSE ASSAY KIT-HEXOKINASE 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 Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K974874BILIRUBIN-SL (TOTAL) ASSAYK932556AMMONIA ASSAY CAT. NO. 200-02K932766HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)K932555DC-LINEATE CAT. NO. SE-091K925877DC-UIBC-CAL

View all 77 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.

↑