Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2518152

FEI Number

2518152

Entity Name

CHRONO-LOG CORP.

City/State/Country

HAVERTOWN, PA, US

Establishment Address

2 WEST PARK RD., HAVERTOWN, PA 19083, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device

Owner / Operator

CHRONO-LOG CORP. (Owner Number: 2518152)

Owner / Operator Contact Address

2 WEST PARK RD., --, Havertown, PA 19083, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K945414

PMA Number

N/A

All Registered Proprietary Names

Chrono-log Platelet Aggregometer, 4 channel Model 490 4+ Chrono-log Platelet Aggregometer, 8 channel Model 490 4+4 Chrono-Par Kit P/N 380 Platelet Aggregation Reagents Arachidonic Acid AGGRO/LINK Control Software CHRONO-LUME Whole Blood Aggregometer WHOLE BLOOD LUMI-AGGREGOMETER AGGRO/LINK vW CoFactor Software Ristocetin Cofactor Assay P/N 299

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOZ	System, Automated Platelet Aggregation	Hematology	Class 2	864.5700	2016-12-27
GHR	Reagent, Platelet Aggregation	Hematology	Class 2	864.5700	2007-11-01
JBX	Aggregrometer, Platelet	Hematology	Class 2	864.6675	2016-01-13
JBX	Aggregrometer, Platelet	Hematology	Class 2	864.6675	2016-09-20
JOZ	System, Automated Platelet Aggregation	Hematology	Class 2	864.5700	2016-01-13
JOZ	System, Automated Platelet Aggregation	Hematology	Class 2	864.5700	1996-05-13
JBX	Aggregrometer, Platelet	Hematology	Class 2	864.6675	2016-09-20
JOZ	System, Automated Platelet Aggregation	Hematology	Class 2	864.5700	2016-09-20
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-11-01

Official Correspondent

Gemal Mahmud

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CHRONO-LOG CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K972288	Universal Reagents, Inc.	FACTOR DEFICIENT PLASMAS - FACTOR IX (9)	1997-07-14
K010379	Instrumentation Laboratory CO	IL TEST FREE PROTEIN S	2001-04-13
K033631	Instrumentation Laboratory CO	MODIFICATION TO COATEST FACTOR VIII	2003-12-15
K924884	Instrumentation Laboratory CO	IL TEST(TM) PRO-CHROM	1993-01-14
K042576	Instrumentation Laboratory CO	COATEST SP FVIII	2004-12-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0736-2016	Instrumentation Laboratory Co.	2	HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
Z-1519-2012	Instrumentation Laboratory Co.	2	Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems

Similar Registrations

Registration Number	Establishment Name	Location
1217183	INSTRUMENTATION LABORATORY CO.	Bedford, MA, US
3002721930	Accriva Diagnostics, Inc.	San Diego, CA, US
3005269352	Invetech Pty Ltd	Mount Waverley Victoria, AU
3016571810	ZACROS CORPORATION MIE FACILITY	NABARI CITY Mie, JP
9610806	Siemens Healthcare Diagnostics Products GmbH	MARBURG Hesse, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2518152. Last updated year: 2026. Please use registration number 2518152 when referencing this establishment in official correspondence.