CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A

System, Automated Platelet Aggregation

CHRONO-LOG CORP.

The following data is part of a premarket notification filed by Chrono-log Corp. with the FDA for Chrono-log Whole Blood Aggregometer, Models 591a And 592a.

Pre-market Notification Details

• Device ID: K032951
• 510k Number: K032951
• Device Name: CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A
• Classification: System, Automated Platelet Aggregation
• Applicant: CHRONO-LOG CORP. 2 WEST PARK RD. Havertown, PA 19083
• Contact: Nicholas J Veriabo
• Correspondent: Nicholas J Veriabo; CHRONO-LOG CORP. 2 WEST PARK RD. Havertown, PA 19083
• Product Code: JOZ
• CFR Regulation Number: 864.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-09-22
• Decision Date: 2004-04-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00811476010437	K032951	000
00811476010420	K032951	000
00811476010390	K032951	000