ASSERACHROM TOTAL PROTEIN S KIT

Test, Qualitative And Quantitative Factor Deficiency

AMERICAN BIOPRODUCTS CO.

The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Asserachrom Total Protein S Kit.

Pre-market Notification Details

• Device ID: K954040
• 510k Number: K954040
• Device Name: ASSERACHROM TOTAL PROTEIN S KIT
• Classification: Test, Qualitative And Quantitative Factor Deficiency
• Applicant: AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. Parsippany, NJ 07054
• Contact: Andrew Loc B Le
• Correspondent: Andrew Loc B Le; AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. Parsippany, NJ 07054
• Product Code: GGP
• CFR Regulation Number: 864.7290 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-08-28
• Decision Date: 1995-11-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03607450009453	K954040	000