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)

CARBON DIOXIDE-SL ASSAY, CAT # 253-01

K-Number: K983019 · 1998-09-14

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1998-09-14
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARBON DIOXIDE-SL ASSAY, CAT # 253-01 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1998-09-14 under 510(k) number K983019. The device is classified under product code KHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARBON DIOXIDE-SL ASSAY, CAT # 253-01?

CARBON DIOXIDE-SL ASSAY, CAT # 253-01 is a medical device that received FDA 510(k) clearance on 1998-09-14. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K983019.

When did CARBON DIOXIDE-SL ASSAY, CAT # 253-01 receive FDA 510(k) clearance?

CARBON DIOXIDE-SL ASSAY, CAT # 253-01 received FDA 510(k) clearance on 1998-09-14, under 510(k) number K983019.

Who is the listed applicant for CARBON DIOXIDE-SL ASSAY, CAT # 253-01?

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

What is the FDA product code for CARBON DIOXIDE-SL ASSAY, CAT # 253-01?

The FDA product code for CARBON DIOXIDE-SL ASSAY, CAT # 253-01 is KHS.

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. 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.

K070383ENZYMATIC CREATININE ASSAY (265 SERIES)K063208MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7K060139CRP-ADVANCE ASSAY, MODELS 250-20, 250-25K060140CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250K051757CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91K051191DCL MICROALBUMIN ASSAY, MODEL 252-20

View all 66 devices →

Related Devices (Code: KHS)

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.

K170200Carbon Dioxide Reagent SetTeco Diagnostics, Inc.K152085Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd.K131546AU BICARBONATE REAGENTBeckman Coulter Ireland, Inc.K123953ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K120765VITROS CHEMISTRY PRODUCTS ECO2 SLIDESOrtho-Clinical Diagnostics, Inc.K113435ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann

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.

↑