CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES

Counter, Differential Cell

CALTAG LABORATORIES, INC.

The following data is part of a premarket notification filed by Caltag Laboratories, Inc. with the FDA for Caltag Cd8 Fitc And Cd8 R-pe Monoclonal Antibodies.

Pre-market Notification Details

• Device ID: K944126
• 510k Number: K944126
• Device Name: CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES
• Classification: Counter, Differential Cell
• Applicant: CALTAG LABORATORIES, INC. 436 ROZZI PLACE South San Francisco, CA 94080
• Contact: Tony Lam
• Correspondent: Tony Lam; CALTAG LABORATORIES, INC. 436 ROZZI PLACE South San Francisco, CA 94080
• Product Code: GKZ
• CFR Regulation Number: 864.5220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-08-23
• Decision Date: 1995-06-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10190302005470	K944126	000
10190302005456	K944126	000
10190302005463	K944126	000
10190302005449	K944126	000