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Chrono-log

FDA UDI

Class II (US FDA UDI)

by Chrono-Log Corp

Identity

Trade Name
Chrono-log FDA UDI
Generic Name
Platelet aggregation analyser IVD FDA UDI
Device Name
Chrono-log Whole Blood Aggregometer (WBA) FDA UDI
Model / Reference
592A FDA UDI
Description
Chrono-log Whole Blood Aggregometer (WBA) FDA UDI

Identifiers

Catalog Number
592A-X FDA UDI
Primary DI / UDI-DI
00811476010437 FDA UDI
510(k) Number
K032951 FDA UDI
FDA Product Code
JOZ FDA UDI
GMDN Term
Platelet aggregation analyser IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5700 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

Yes

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: Platelet aggregation analyser IVD

Chrono-log by Chrono-Log Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Platelet aggregation analyser IVD.

Cleared under the same submission

K032951 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Chrono-Log Corp

Sources (1)

  • FDA UDI 11bd1874-5af0-470f-b9c1-f936ca0488e4 36 fields · synced May 30, 2026