Calcium Na/K/Ca/pH Analyzer

FDA UDI

Class II (US FDA UDI)

by Medica Corp.

Identity

Trade Name: Calcium Na/K/Ca/pH Analyzer FDA UDI
Generic Name: Ion-selective analyser IVD FDA UDI
Device Name: EasyLyte Calcium Na/K/Ca/pH Analyzer FDA UDI
Model / Reference: 2016 FDA UDI
Description: EasyLyte Calcium Na/K/Ca/pH Analyzer FDA UDI

Identifiers

Catalog Number: 2016 FDA UDI
Primary DI / UDI-DI: 00386100002893 FDA UDI
510(k) Number: K943091 FDA UDI
FDA Product Code: CHL FDA UDI
JGS FDA UDI
CEM FDA UDI
JFP FDA UDI
GMDN Term: Ion-selective analyser IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1120 FDA UDI
862.1665 FDA UDI
862.1600 FDA UDI
862.1145 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ion-selective analyser IVD

Calcium Na/K/Ca/pH Analyzer by Medica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K943091 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medica Corp.

Sources (1)

FDA UDI 9825a4bb-d353-4cf9-87a6-f24802c1ae4d 37 fields · synced May 30, 2026