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FreeStyle Precision Pro

FDA UDI

Class II (US FDA UDI)

by Abbott Diabetes Care Inc

Identity

Trade Name
FreeStyle Precision Pro FDA UDI
Generic Name
Multiple clinical chemistry analyte monitoring system IVD, point-of-care FDA UDI
Device Name
FreeStyle Precision Pro Blood ß-Ketone Test Strips FDA UDI
Model / Reference
71288 FDA UDI
Description
FreeStyle Precision Pro Blood ß-Ketone Test Strips FDA UDI

Identifiers

Catalog Number
71288 FDA UDI
Primary DI / UDI-DI
00093815712886 FDA UDI
510(k) Number
K132511 FDA UDI
FDA Product Code
LFR FDA UDI
JQP FDA UDI
JIN FDA UDI
NBW FDA UDI
GMDN Term
Multiple clinical chemistry analyte monitoring system IVD, point-of-care FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 FDA UDI
862.2100 FDA UDI
862.1435 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple clinical chemistry analyte monitoring system IVD, point-of-care

FreeStyle Precision Pro by Abbott Diabetes Care Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry analyte monitoring system IVD, point-of-care.

Cleared under the same submission

K132511 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Diabetes Care Inc

Sources (1)

  • FDA UDI 4478ff9c-b178-45bb-ab61-81f3ada15082 37 fields · synced May 30, 2026