ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040

Single (specified) Analyte Controls (assayed And Unassayed)

SIGMA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Ace Controls, Normal & Elevated, No. A6040 & A7040.

Pre-market Notification Details

• Device ID: K860453
• 510k Number: K860453
• Device Name: ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040
• Classification: Single (specified) Analyte Controls (assayed And Unassayed)
• Applicant: SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178
• Contact: Crider, Phd
• Correspondent: Crider, Phd; SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178
• Product Code: JJX
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-02-05
• Decision Date: 1986-02-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05391516747240	K860453	000
05391516747233	K860453	000