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FDA 510(k)

SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM

K-Number: K896467 · 1990-06-12

ApplicantMedisense, Inc.
Decision Date1990-06-12
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medisense, Inc.. It received FDA 510(k) clearance on 1990-06-12 under 510(k) number K896467. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM?

SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1990-06-12. The listed applicant is Medisense, Inc.. The 510(k) number is K896467.

When did SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM receive FDA 510(k) clearance?

SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM received FDA 510(k) clearance on 1990-06-12, under 510(k) number K896467.

Who is the listed applicant for SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM?

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

What is the FDA product code for SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM?

The FDA product code for SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM is CHH.

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Other records listing Medisense, 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.

K983504PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST STK982303PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST STK983253PRECISION A1C HOME HBA1C SAMPLE COLLECTION KITK971812PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIPK963676PRECISION G BLOOD GLUCOSE TESTING SYSTEMK962295PRECISION QID BLOOD GLUCOSE TEST STRIP

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Related Devices (Code: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, 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.

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