FDA.reportPublic FDA data

Chrono-log

Primary DI
00811476010482
Brand
Chrono-log
Company
CHRONO-LOG CORP
Model
700
Catalog number
700-2
Device description
Whole Blood Lumi-Aggregometer
Published
2016-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOZSystem, Automated Platelet Aggregation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOZSystem, Automated Platelet AggregationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050265000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050265000CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700Chrono-Log Corp.2005-10-14JOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811476010482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811476010482008114760104828114760104820811476010482

GMDN Terms#

Term, Definition table
TermDefinition
Platelet aggregation analyser IVD, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro examination of platelet function in a clinical specimen, by inducing platelet aggregation through the addition of platelet aggregating agents. The instrument may incorporate various technologies including electrical impedance, photometry, turbidimetry and/or luminescence together with sample processing, data processing and/or data display software. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
610-853-1130chronolog@chronolog.com

Regulatory Flags#

DUNS number
002353696
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811476011007CHRONO-LOGAGGRO/LINK WBA Software2023-06-21
00811476011021CHRONO-LOGAGGRO/LINK8 Software2023-06-21
00811476011045CHRONO-LOGvW CoFactor Software2023-06-21
00811476011663CHRONO-LOGAGGRO/LINK Opti8 Software2023-06-21
00811476011670CHRONO-LOGvW CoFactor Opti8 Software2023-06-21
00811476010246Chrono-log490490-2D2016-10-11
00811476010253Chrono-log490490-X2016-10-11
00811476010369Chrono-log590590-2D2016-10-11
00811476010376Chrono-log590590-X2016-10-11
00811476010383Chrono-log5915912016-10-11
00811476010390Chrono-log591A591A2016-10-11
00811476010406Chrono-log5925922016-10-11
00811476010413Chrono-log592592-X2016-10-11
00811476010420Chrono-log592A592A2016-10-11
00811476010437Chrono-log592A592A-X2016-10-11
00811476010499Chrono-log700700-X2016-10-11
00811476010956Chrono-log490490-4D2016-10-11
00811476010963Chrono-log590590-4D2016-10-11
00811476010987Chrono-log490 4+490 4+2016-12-28
00811476010994Chrono-log490 4+4490 4+42016-12-28

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10812747018302TEG6s HEMOSTASIS SYSTEMHAEMONETICS CORPORATIONJOZ2017-08-18
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