Actalyke XL, (CSA/CE), W/ Flash Memory

FDA UDI

Class II (US FDA UDI)

by Helena Laboratories, Corp.

Identity

Trade Name: Actalyke XL, (CSA/CE), W/ Flash Memory FDA UDI
Generic Name: Coagulation analyser IVD, laboratory FDA UDI
Model / Reference: 5770004 FDA UDI

Identifiers

Primary DI / UDI-DI: M52557700040 FDA UDI
510(k) Number: K020914 FDA UDI
FDA Product Code: JBP FDA UDI
GMDN Term: Coagulation analyser IVD, laboratory FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7140 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

FDA UDI

Category: Coagulation analyser IVD, laboratory

Actalyke XL, (CSA/CE), W/ Flash Memory by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K020914 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: Helena Laboratories, Corp.

Sources (1)

FDA UDI 1da00586-f32c-421a-a4e1-069904db4067 34 fields · synced Jun 9, 2026