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)

DIAG. OZYRATE GLUCOSE REAG. SET

K-Number: K771059 · 1977-07-21

ApplicantJ.T. Baker Chemical Co.
Decision Date1977-07-21
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAG. OZYRATE GLUCOSE REAG. SET is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1977-07-21 under 510(k) number K771059. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAG. OZYRATE GLUCOSE REAG. SET?

DIAG. OZYRATE GLUCOSE REAG. SET is a medical device that received FDA 510(k) clearance on 1977-07-21. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K771059.

When did DIAG. OZYRATE GLUCOSE REAG. SET receive FDA 510(k) clearance?

DIAG. OZYRATE GLUCOSE REAG. SET received FDA 510(k) clearance on 1977-07-21, under 510(k) number K771059.

Who is the listed applicant for DIAG. OZYRATE GLUCOSE REAG. SET?

The FDA 510(k) record lists J.T. Baker Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAG. OZYRATE GLUCOSE REAG. SET?

The FDA product code for DIAG. OZYRATE GLUCOSE REAG. SET is CGA.

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 J.T. Baker Chemical Co. 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.

K803128SERIES 810 PLATELET ANALYZERK802080BAKER DIAG. ULTRARATE CHLORIDE KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRIC

View all 54 devices →

Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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.

↑