HEMAPROMPT

Reagent, Occult Blood

AERSCHER DIAGNOSTICS

The following data is part of a premarket notification filed by Aerscher Diagnostics with the FDA for Hemaprompt.

Pre-market Notification Details

• Device ID: K972763
• 510k Number: K972763
• Device Name: HEMAPROMPT
• Classification: Reagent, Occult Blood
• Applicant: AERSCHER DIAGNOSTICS 353 HIGH ST. Chestertown, MD 21620
• Contact: Robert Schreiber
• Correspondent: Robert Schreiber; AERSCHER DIAGNOSTICS 353 HIGH ST. Chestertown, MD 21620
• Product Code: KHE
• CFR Regulation Number: 864.6550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-07-24
• Decision Date: 1997-10-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00693501000152	K972763	000