FREEZE DRIED PAPAIN

Solution, Stabilized Enzyme

BIOLOGICAL CORP. OF AMERICA

The following data is part of a premarket notification filed by Biological Corp. Of America with the FDA for Freeze Dried Papain.

Pre-market Notification Details

• Device ID: K810803
• 510k Number: K810803
• Device Name: FREEZE DRIED PAPAIN
• Classification: Solution, Stabilized Enzyme
• Applicant: BIOLOGICAL CORP. OF AMERICA 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KSK
• CFR Regulation Number: 864.9400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-03-24
• Decision Date: 1981-07-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888234000990	K810803	000