SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)

System, Fibrinogen Determination

SIGMA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Sigma Diagnostics Fibrinogen Kit (886a/887a).

Pre-market Notification Details

• Device ID: K971858
• 510k Number: K971858
• Device Name: SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
• Classification: System, Fibrinogen Determination
• Applicant: SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103
• Contact: William R Gilbert
• Correspondent: William R Gilbert; SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103
• Product Code: KQJ
• CFR Regulation Number: 864.7340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-05-20
• Decision Date: 1997-10-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05391521420350	K971858	000
15391521420722	K971858	000
15391521420500	K971858	000
15391521420364	K971858	000