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)

FAST GLUCOSE

K-Number: K870631 · 1987-03-13

ApplicantSclavo, Inc.
Decision Date1987-03-13
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FAST GLUCOSE is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1987-03-13 under 510(k) number K870631. 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 FAST GLUCOSE?

FAST GLUCOSE is a medical device that received FDA 510(k) clearance on 1987-03-13. The listed applicant is Sclavo, Inc.. The 510(k) number is K870631.

When did FAST GLUCOSE receive FDA 510(k) clearance?

FAST GLUCOSE received FDA 510(k) clearance on 1987-03-13, under 510(k) number K870631.

Who is the listed applicant for FAST GLUCOSE?

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

What is the FDA product code for FAST GLUCOSE?

The FDA product code for FAST GLUCOSE 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 Sclavo, 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.

K914789ELISA CMV IGMK914852ELISA TOXO IGMK914420ELISA RUBELLA IGMK895943NORMAL AND ABNORMAL CONTROL SERAK895822TOTAL BILIRUBIN L.F.K895847CREATININE 340 (ENZYMATIC)

View all 82 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.

↑