CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY

Counter, Differential Cell

CALTAG LABORATORIES, INC.

The following data is part of a premarket notification filed by Caltag Laboratories, Inc. with the FDA for Cd 19 R-pe, Cd19 Tri-color Monoclonal Antibody.

Pre-market Notification Details

• Device ID: K963954
• 510k Number: K963954
• Device Name: CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY
• Classification: Counter, Differential Cell
• Applicant: CALTAG LABORATORIES, INC. 605 DILWORTH RD. Downingtown, PA 19335
• Contact: David C Bishop
• Correspondent: David C Bishop; CALTAG LABORATORIES, INC. 605 DILWORTH RD. Downingtown, PA 19335
• Product Code: GKZ
• CFR Regulation Number: 864.5220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-10-02
• Decision Date: 1996-11-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10190302005494	K963954	000
10190302005517	K963954	000
10190302005500	K963954	000