REPTILASE-R HA35

Bothrops Atrox Reagent

WELLCOME DIAGNOSTICS

The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Reptilase-r Ha35.

Pre-market Notification Details

• Device ID: K840210
• 510k Number: K840210
• Device Name: REPTILASE-R HA35
• Classification: Bothrops Atrox Reagent
• Applicant: WELLCOME DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JCO
• CFR Regulation Number: 864.8100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-01-19
• Decision Date: 1984-04-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
13607450006145	K840210	000