CHECK UP AMERICA CHOLESTEROL PANEL

Primary DI
M769CHOLESTEROL801
Brand
CHECK UP AMERICA CHOLESTEROL PANEL
Company
Home Access Health Corporation
Model
80
Device description
Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used in the diagnosis and treatment of disorders involving excess cholesterol in the blood.
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063852000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063852000ACCESSA CHOLESTEROL PANELHome Access Health Corp.2007-11-09JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M769CHOLESTEROL801PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Home blood collection kitA collection of devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection strip, dry blood collection card/filter paper card, and other items (e.g., alcohol prep pad, disposable lancet, gauze pad, bandage strip, and a container with a requisition form, for mailing to the laboratory). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
848511283
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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M769HIVEXPRESS201Express HIV-1 Test System202015-09-03
M769FITCHEK351FIT-CHEK352016-09-09
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M769FITCHEK331FIT-CHEK332019-06-22
M769FITCHEK341FIT-CHEK342018-06-26
M769MAUTEST371URINE COLLECTION KIT372020-09-18
M769MAUTEST391URINE COLLECTION KIT392020-09-19