510(k) K864033

Device: Rapid Acid Fast Stain
Applicant: SIGMA DIAGNOSTICS, INC.
510(k) number: K864033
Product code: KJY
Decision: Substantially Equivalent (SESE)
Decision date: 1986-11-13
Date received: 1986-10-15
Regulation: 864.1850
Classification name: Malachite Green
Medical specialty: Hematology
Review panel: Hematology
Device class: 1
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Contact: WILLIAM STARKWEATHER
Address: P.O. Box 14508 St. Louis MO US 63178 63178

FDA Registration Numbers#

9610140
1000138378
2013736
1937990
3009432145
2247035
2250039
1045125

Source Documents#

510(k) summary PDF not indicated by FDA