DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS

System, Automated Platelet Aggregation

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dade Pfa-100 Platelet Function Analyzer And Reagents.

Pre-market Notification Details

• Device ID: K060489
• 510k Number: K060489
• Device Name: DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
• Classification: System, Automated Platelet Aggregation
• Applicant: DADE BEHRING, INC. BLDG. 500 MAIL BOX 514 P.O. BOX 6101 Newark, DE 19714 -6101
• Contact: Radames Riesgo
• Correspondent: Radames Riesgo; DADE BEHRING, INC. BLDG. 500 MAIL BOX 514 P.O. BOX 6101 Newark, DE 19714 -6101
• Product Code: JOZ
• CFR Regulation Number: 864.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-02-24
• Decision Date: 2006-07-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768024870	K060489	000
00842768003691	K060489	000
00842768003684	K060489	000
00842768003660	K060489	000