Acl Top 700 Cts

FDA UDIFDA 510(k)

Class II (US FDA UDI)

510(k) K160276

by Instrumentation Laboratory Company

Identity

Trade Name: ACL TOP 700 CTS FDA UDI
Generic Name: Coagulation analyser IVD, laboratory FDA UDI
Device Name: ACL TOP 700 CTS (Refurbished) FDA UDI
Model / Reference: 00000280050R FDA UDI
Description: ACL TOP 700 CTS (Refurbished) FDA UDI

Identifiers

Catalog Number: 00000280050R FDA UDI
Primary DI / UDI-DI: 08426950928010 FDA UDI
510(k) Number: K160276 FDA UDI
FDA Product Code: GKP FDA UDI
GMDN Term: Coagulation analyser IVD, laboratory FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5400 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

Acl Top 700 Cts by Instrumentation Laboratory Company — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

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Also classified as Coagulation analyser IVD, laboratory.

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TEG5000 HEMOSTASIS SYSTEM — HAEMONETICS CORPORATION · Class II
Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
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Helena Electronic Clotting Tube — Helena Laboratories, Corp. · Class I
Actalyke Thermometer — Helena Laboratories, Corp. · Class I

Cleared under the same submission

K160276 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K160276	Class II	Active

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Manufacturer

Manufacturer: Instrumentation Laboratory Company
FDA Applicant: Instrumentation Laboratory CO

Sources (2)

FDA UDI 16e77e50-787d-4c8c-a0d0-e9501f1c8dce 60 fields · synced Jun 18, 2026
FDA 510(k) K160276 1 fields · synced May 25, 2026