CHECKPOINT

Mixture, Hematology Quality Control

MEDICAL SPECIALTIES, INC.

The following data is part of a premarket notification filed by Medical Specialties, Inc. with the FDA for Checkpoint.

Pre-market Notification Details

• Device ID: K931947
• 510k Number: K931947
• Device Name: CHECKPOINT
• Classification: Mixture, Hematology Quality Control
• Applicant: MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield, NJ 07080
• Contact: Kevin Liddle
• Correspondent: Kevin Liddle; MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield, NJ 07080
• Product Code: JPK
• CFR Regulation Number: 864.8625 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-04-19
• Decision Date: 1993-06-18