ELITECH CLINICAL SYSTEMS CK NAC SL

U.v. Method, Cpk Isoenzymes

ELITECHGROUP

The following data is part of a premarket notification filed by Elitechgroup with the FDA for Elitech Clinical Systems Ck Nac Sl.

Pre-market Notification Details

• Device ID: K122083
• 510k Number: K122083
• Device Name: ELITECH CLINICAL SYSTEMS CK NAC SL
• Classification: U.v. Method, Cpk Isoenzymes
• Applicant: ELITECHGROUP 21720 23RD DR SE SUITE 150 Bothell, WA 98021
• Contact: Debra K Hutson
• Correspondent: Debra K Hutson; ELITECHGROUP 21720 23RD DR SE SUITE 150 Bothell, WA 98021
• Product Code: JHW
• Subsequent Product Code: JIX
• Subsequent Product Code: JJY
• CFR Regulation Number: 862.1215 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-07-16
• Decision Date: 2012-08-22
• Summary: summary