IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)

Enzyme Immunoassay, Digoxin

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2000 Digoxin, Models L2kdi2 (200 Tests) And L2kdi6 (600 Tests).

Pre-market Notification Details

• Device ID: K012301
• 510k Number: K012301
• Device Name: IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
• Classification: Enzyme Immunoassay, Digoxin
• 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: KXT
• CFR Regulation Number: 862.3320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-07-20
• Decision Date: 2001-09-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630414963860	K012301	000
00630414961286	K012301	000