← Back to catalogue

CLINITEK Status® Connector

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
CLINITEK Status® Connector FDA UDI
Generic Name
Multichannel clinical chemistry analyser IVD, laboratory FDA UDI
Device Name
The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity andcentralized control of all the satellite Point of Care (POC) Clinitek Status+ analyzers. The connector communicates with remote hospital and Laboratory Information Systems (HIS/LIS) and interfaces with Electronic Medical Records (EMR). FDA UDI
Model / Reference
10376322 FDA UDI
Description
The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity andcentralized control of all the satellite Point of Care (POC) Clinitek Status+ analyzers. The connector communicates with remote hospital and Laboratory Information Systems (HIS/LIS) and interfaces with Electronic Medical Records (EMR). FDA UDI

Identifiers

Catalog Number
10376322 FDA UDI
Primary DI / UDI-DI
00630414571263 FDA UDI
510(k) Number
K091216 FDA UDI
FDA Product Code
KQO FDA UDI
CDM FDA UDI
CEN FDA UDI
JMT FDA UDI
LJX FDA UDI
JJB FDA UDI
JIL FDA UDI
JRE FDA UDI
JIP FDA UDI
JHI FDA UDI
JIR FDA UDI
JFY FDA UDI
JIN FDA UDI
GMDN Term
Multichannel clinical chemistry analyser IVD, laboratory FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2900 FDA UDI
862.1785 FDA UDI
862.1550 FDA UDI
862.1510 FDA UDI
864.7675 FDA UDI
862.1115 FDA UDI
862.1340 FDA UDI
862.2800 FDA UDI
864.6550 FDA UDI
862.1155 FDA UDI
862.1645 FDA UDI
862.1225 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multichannel clinical chemistry analyser IVD, laboratory

CLINITEK Status® Connector by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multichannel clinical chemistry analyser IVD, laboratory.

Cleared under the same submission

K091216 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 1012d2fc-e5ba-46fb-ae70-add6a16ed0d3 37 fields · synced Jun 6, 2026