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RAPIDChem® 700 Lithium Sensor

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
RAPIDChem® 700 Lithium Sensor FDA UDI
Generic Name
Lithium electrode IVD FDA UDI
Device Name
RAPIDChem® 700 Lithium Sensor for in vitro diagnostics use with the Rapidchem ® 700 systems FDA UDI
Model / Reference
10308981 FDA UDI
Description
RAPIDChem® 700 Lithium Sensor for in vitro diagnostics use with the Rapidchem ® 700 systems FDA UDI

Identifiers

Catalog Number
583772 FDA UDI
Primary DI / UDI-DI
00630414451862 FDA UDI
510(k) Number
K002407 FDA UDI
FDA Product Code
JGS FDA UDI
CEM FDA UDI
JIH FDA UDI
GMDN Term
Lithium electrode IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1665 FDA UDI
862.1600 FDA UDI
862.3560 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

No

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: Lithium electrode IVD

RAPIDChem® 700 Lithium Sensor by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lithium electrode IVD.

Cleared under the same submission

K002407 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI cdf1e5f2-c0ce-4eea-9205-7dc96058b901 37 fields · synced May 30, 2026