JTS · Class I · 21 CFR 864.1850

FDA Product Code JTS: Stains, Microbiologic

Leading manufacturers include Remel Co., Alpha-Tec Systems, Inc. and Accra Laboratories, Inc..

40
Total
40
Cleared
39d
Avg days
1978
Since
40 devices
25–40 of 40
Cleared Apr 29, 1985
TWO-STEP ACID FAST BACTERIA STAIN
K851494
Accra Laboratories, Inc.
Pathology · 14d
Cleared Sep 14, 1984
GRAM STAIN SET W/STABILIZED IODINE
K843429
Accra Laboratories, Inc.
Pathology · 10d
Cleared Sep 11, 1984
GRAM STAIN
K843050
Reagent Laboratory, Inc.
Microbiology · 39d
Cleared Jun 08, 1983
TRICHROME STAIN
K831060
American Micro Scan
Pathology · 68d
Cleared May 27, 1982
FAST VIOLET B
K821038
Dms Laboratories
Microbiology · 44d
Cleared Dec 22, 1981
GRAM STAIN REAGENTS AND KIT
K813369
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 22d
Cleared Sep 29, 1981
AFB STAIN SET
K812668
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 8d
Cleared Jul 27, 1981
ACCRA-LAB GRAM STAIN SET 55760
K811780
Accra Laboratories, Inc.
Pathology · 34d
Cleared Aug 14, 1978
DROPPERS, SOLUTION, IODINE
K781061
Marion Laboratories, Inc.
Chemistry · 49d
Cleared Mar 22, 1978
MIF PROCEDURE KIT
K780346
Marion Laboratories, Inc.
Immunology · 21d