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Precision Xceed Pro

FDA UDI

Class II (US FDA UDI)

by Abbott Diabetes Care Inc

Identity

Trade Name
Precision Xceed Pro FDA UDI
Generic Name
Multiple clinical chemistry analyte monitoring system IVD, point-of-care FDA UDI
Device Name
Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System FDA UDI
Model / Reference
70900-04 FDA UDI
Description
Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System FDA UDI

Identifiers

Catalog Number
70900-04 FDA UDI
Primary DI / UDI-DI
00357599000158 FDA UDI
510(k) Number
K080960 FDA UDI
FDA Product Code
NBW FDA UDI
LFR FDA UDI
JIN 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
862.1435 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Precision Xceed 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

K080960 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 ad74a9ef-45d9-48b2-ac50-b450a9b97845 37 fields · synced May 30, 2026