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 May 15, 1987
SPOTTEST FLAGELLA STAIN
K871606
Difco Laboratories, Inc.
Pathology · 21d
Cleared Apr 29, 1987
TOMTEC GRAM STAINER CRYSTAL VIOLET
K871532
Remel Co.
Pathology · 9d
Cleared Mar 30, 1987
PRICE'S ACID-FAST STAIN
K870988
Devetec, Inc.
Pathology · 19d
Cleared Oct 22, 1985
GRAM STAIN KIT
K853896
Sigma Diagnostics, Inc.
Pathology · 32d
Cleared Apr 29, 1985
KINYOUN ACID FAST STAIN KIT
K851493
Accra Laboratories, Inc.
Pathology · 14d
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 Oct 03, 1978
ACID FAST KIT
K781643
Bioscientific
Pathology · 8d
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