BIOSIGN

Indicator, Biological Sterilization Process

CLINICAL TECHNOLOGY CORP.

The following data is part of a premarket notification filed by Clinical Technology Corp. with the FDA for Biosign.

Pre-market Notification Details

• Device ID: K872867
• 510k Number: K872867
• Device Name: BIOSIGN
• Classification: Indicator, Biological Sterilization Process
• Applicant: CLINICAL TECHNOLOGY CORP. 3750 MONROE AVE. P.O. BOX 23245 Rochester, NY 14692
• Contact: Scoville, Jr
• Correspondent: Scoville, Jr; CLINICAL TECHNOLOGY CORP. 3750 MONROE AVE. P.O. BOX 23245 Rochester, NY 14692
• Product Code: FRC
• CFR Regulation Number: 880.2800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-07-21
• Decision Date: 1988-07-06