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

FDA 510(k) Cleared Stains, Microbiologic Devices (Product Code JTS)

40 devices
1–24 of 40
Cleared Mar 19, 1996
CALCOFLUOR WHITE STAIN KIT
K960090
Remel Co.
Microbiology · 68d
Cleared Mar 19, 1996
BACTIDROP CALCOFLUOR WHITE
K960095
Remel Co.
Microbiology · 68d
Cleared Jun 09, 1992
BACTIDROP KOH (10%)
K920970
Remel Co.
Pathology · 99d
Cleared Jun 09, 1992
BACTIDROP CALCOFLUOR WHITE
K920975
Remel Co.
Pathology · 99d
Cleared Jun 09, 1992
BACTIDROP INDIA INK
K920976
Remel Co.
Pathology · 99d
Cleared Jun 13, 1989
IRISTAIN FORMULA 2, PARTS 1 AND 2
K893530
Intl. Remote Imaging Systems
Pathology · 36d
Cleared Mar 23, 1989
ATS DOBELL & O'CONNOR'S IODINE
K890861
Alpha-Tec Systems, Inc.
Pathology · 30d
Cleared Feb 24, 1989
ATS LUGOL'S IODINE SOLUTION
K890020
Alpha-Tec Systems, Inc.
Pathology · 51d
Cleared Oct 25, 1988
SNAP N' STAIN IODINE STAIN
K884069
Scientific Device Laboratory, Inc.
Pathology · 28d
Cleared Aug 30, 1988
METHENO-STAIN KIT
K883052
Scientific Device Laboratory, Inc.
Pathology · 42d
Cleared Aug 17, 1988
ATS PARA-SET IODINE ALCOHOL SOLUTION
K883049
Alpha-Tec Systems, Inc.
Pathology · 29d
Cleared Aug 17, 1988
ATS PARA-SET CARBOL-XYLENE SOLUTION
K883061
Alpha-Tech Systems, Inc.
Pathology · 29d
Cleared May 13, 1988
ATS CRYPTOSPORIDIUM STAIN SET
K880989
Alpha-Tec Systems, Inc.
Pathology · 66d
Cleared May 04, 1988
SDL TRICHROME STAIN
K881598
Scientific Device Laboratory, Inc.
Pathology · 21d
Cleared Apr 18, 1988
WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY
K881512
Wescor, Inc.
Pathology · 7d
Cleared Mar 30, 1988
ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION)
K881042
Alpha-Tec Systems, Inc.
Pathology · 19d
Cleared Mar 25, 1988
CALCOFLUOR WHITE STAIN KIT
K880718
Remel Co.
Pathology · 31d
Cleared Nov 25, 1987
MYCO-FLUOR REAGENT A & B
K874662
Scott Laboratories, Inc.
Pathology · 12d
Cleared Oct 06, 1987
GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR
K873413
Lakewood Biochemical Co., Inc.
Pathology · 43d
Cleared Jul 29, 1987
TB METHYLENE BLUE
K872184
Remel Co.
Pathology · 51d
Cleared Jul 29, 1987
LIGHT GREEN
K872185
Remel Co.
Pathology · 51d
Cleared Jul 29, 1987
SULFURIC ACID 10%
K872186
Remel Co.
Pathology · 51d
Cleared Jul 29, 1987
TB KINYOUN CARBOLFUCHSIN
K872187
Remel Co.
Pathology · 51d
Cleared Jul 29, 1987
METHANOL, ABSOLUTE
K872189
Remel Co.
Pathology · 51d

About Product Code JTS - Regulatory Context