IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15

Immunoassay Method, Troponin Subunit

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Troponin I, Model Lkti1 And Lkt15.

Pre-market Notification Details

• Device ID: K983972
• 510k Number: K983972
• Device Name: IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15
• Classification: Immunoassay Method, Troponin Subunit
• Applicant: DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597
• Contact: Edward M Levine
• Correspondent: Edward M Levine; DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597
• Product Code: MMI
• CFR Regulation Number: 862.1215 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-11-09
• Decision Date: 1998-12-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630414986098	K983972	000
00630414986074	K983972	000
00630414954394	K983972	000