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 TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA

K-Number: K864282 · 1987-05-26

ApplicantMedical Device Consultants, Inc.
Decision Date1987-05-26
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Consultants, Inc.. It received FDA 510(k) clearance on 1987-05-26 under 510(k) number K864282. 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 GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA?

GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA is a medical device that received FDA 510(k) clearance on 1987-05-26. The listed applicant is Medical Device Consultants, Inc.. The 510(k) number is K864282.

When did GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA receive FDA 510(k) clearance?

GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA received FDA 510(k) clearance on 1987-05-26, under 510(k) number K864282.

Who is the listed applicant for GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA?

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

What is the FDA product code for GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA?

The FDA product code for GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA 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 Medical Device Consultants, 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.

K022895ELCAM STOPCOCKS AND MANIFOLDSK002699PARIETEX COMPOSITE (PCO) MESHK002116S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0K000551IMAGE X-70 PLUS DENTAL X-RAY UNITK974164SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBEK860122HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME

View all 14 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.

↑