ROUND 1

Kit, Screening, Urine

BIOCLINICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Bioclinical Systems, Inc. with the FDA for Round 1.

Pre-market Notification Details

• Device ID: K873086
• 510k Number: K873086
• Device Name: ROUND 1
• Classification: Kit, Screening, Urine
• Applicant: BIOCLINICAL SYSTEMS, INC. 9130-B GUILFORD RD. Columbia, MD 21046
• Contact: John H Powers
• Correspondent: John H Powers; BIOCLINICAL SYSTEMS, INC. 9130-B GUILFORD RD. Columbia, MD 21046
• Product Code: JXA
• CFR Regulation Number: 866.2660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-08-06
• Decision Date: 1987-08-24