PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT

Antisera, All Groups, Streptococcus Spp.

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Patho Dx Latex Agglutination Strep Grouping Kit.

Pre-market Notification Details

• Device ID: K871831
• 510k Number: K871831
• Device Name: PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT
• Classification: Antisera, All Groups, Streptococcus Spp.
• Applicant: DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597
• Contact: Paul Durham
• Correspondent: Paul Durham; DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597
• Product Code: GTZ
• CFR Regulation Number: 866.3740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-05-11
• Decision Date: 1987-06-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05056080501536	K871831	000
05056080501246	K871831	000
05056080501253	K871831	000
05056080501260	K871831	000
05056080501277	K871831	000
05056080501284	K871831	000
05056080501291	K871831	000
05056080501352	K871831	000
05056080501369	K871831	000
05056080501239	K871831	000