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)

SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.

K-Number: K864530 · 1987-02-18

ApplicantMiles Laboratories, Inc.
Decision Date1987-02-18
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1987-02-18 under 510(k) number K864530. 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 SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.?

SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. is a medical device that received FDA 510(k) clearance on 1987-02-18. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K864530.

When did SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. receive FDA 510(k) clearance?

SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. received FDA 510(k) clearance on 1987-02-18, under 510(k) number K864530.

Who is the listed applicant for SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.?

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

What is the FDA product code for SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.?

The FDA product code for SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. 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 Miles Laboratories, 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.

K880605LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTERK874909MICRO-BUMINTEST REAGENT TABLETSK875079MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULEK871835GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINTK872120SERALYZER III BLOOD CHEMISTRY ANALYZERK873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)

View all 158 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.

↑