IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)

System, Test, Radioallergosorbent (rast) Immunological

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2000 Allergen-specific Ige And Specific Allergens, Mdoel L2kun6 (600 Tests).

Pre-market Notification Details

• Device ID: K013134
• 510k Number: K013134
• Device Name: IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)
• Classification: System, Test, Radioallergosorbent (rast) Immunological
• Applicant: DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597
• Contact: Edwards M Levine
• Correspondent: Edwards M Levine; DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597
• Product Code: DHB
• CFR Regulation Number: 866.5750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-09-19
• Decision Date: 2001-10-15
• Summary: summary

NIH GUDID Devices

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