Product code JTO— Microbiology
BACTICARD STREP
- Classification name
- Discs, Strips And Reagents, Microorganism Differentiation
- Device class
- Class 1
- Regulation
- 21 CFR 866.2660
- Advisory panel
- Microbiology
- Total cleared
- 244
- First cleared
- Most recent
Market context for product code JTO
FDA has cleared devices under product code JTO between 1976 and 2005, filed by 50 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2005
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
Top applicants under product code JTO
Recent clearances under product code JTO
1–100 of 244- K050352 — IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT
- K970832 — PYR SWAB
- K970834 — GRAM SWAB
- K970833 — INDOLE SWAB
- K970009 — LYFO(TM) DIFFERENTIAL DISK-BACITRACIN
- K962966 — IDS RAPID CB PLUS SYSTEM
- K961191 — COLISCREEN
- K960996 — M. CAT BUTYRATE DISK
- K955826 — GIBSON ID-M. CAT.
- K954783 — DRYSLIDE CARTARRHALIS
- K954812 — LYFO(TM) DIFFERIENTAL DISK-PYR
- K953247 — GIBSON ID A.E. TEST
- K951889 — LYFO(TM) DIFFERENTIAL DISK
- K950346 — B-L RED(TM) DISCS
- K945880 — LYFO(TM) DIFFERENTIAL DISK-SPS
- K945881 — LYFO(TM) DIFFERENTIAL DISK-STERILE DISK
- K945882 — LYFO(TM) DIFFERENTIAL DISK-BILE
- K945883 — LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN
- K934130 — SWABZYME OXIDASE
- K934125 — GONOCHEK-II, MODIFICATION
- K940161 — B-LACTAMASE REAGENT TUBES
- K940162 — GONOCHEK II REAGENT TUBES
- K934129 — STREP-A-CHEK
- K940020 — STREP-A-CHEK(TM) REAGENT STRIPS
- K940124 — EY-20 REAGENT TUBES
- K941111 — STREP-SURE A/E
- K941016 — DISPENS-O-DISC(TM) NITROCEFIN
- K936021 — BACTICARD STREP
- K936034 — SERIM PYLORITEK REAGENT STRIPS
- K934986 — BACTICARD E. COLI
- K931865 — PYR TEST KIT
- K932752 — VISI-SPOT
- K933514 — BACTICARD STREP
- K931862 — NINHYDRIN REAGENT
- K930693 — OXYSTRIP
- K931414 — CATALASE REAGENT
- K930878 — BACTIDROP(TM) MUCAP
- K931413 — FERRIC CHLORID REAGENT, 10%
- K930717 — NITRATE REAGENTS A, B AND C
- K930718 — INDOLE SPOT & INDOLE KOVACS REAGENT
- K930720 — VOGUES-PROSKAUER REAGENT A & B
- K926254 — BBL PYR REAGENT DROPPERS
- K926255 — BBL NITRATE A, B REAGENT DROPPERS
- K926256 — BBL NINHYDRIN REAGENT DROPPERS
- K925747 — DRYSLIDE(TM) INDOLE
- K923700 — INDOXYL ACETATE DISK
- K923827 — LAP DISK
- K920973 — BACTIDROP INDOLE (ERLICH'S)
- K921583 — DRYSLIDE(TM), PYR
- K920971 — BACTIDROP NINHYDRIN
- K920972 — BACTIDROP PYR
- K920257 — NIACIN CONTROL DISKS
- K913002 — BACTIDROP(TM) FERRIC CHLORIDE (10%)
- K913003 — BACTIDROP(TM) VOGES-PROSKAUER A
- K913006 — BACTIDROP(TM) DOBELL & O'CONNOR IODINE
- K913007 — BACTIDROP(TM) VOGES-PROSKAUER B
- K913008 — BACTIDROP(TM) OXIDASE
- K913010 — BACTIDROP (TM) NITRATE B
- K913011 — BACTIDROP(TM) NITRATE A
- K913001 — BACTIDROP(TM) DESOXYCHOLATE (10%)
- K913004 — BACTIDROP(TM) SPOT INDOLE
- K913009 — BACTIDROP(TM) INDOLE (KOVACS)
- K912480 — BBL(R) DMACA INDOLE REAGENT DROPPERS
- K905472 — LAP DISCS
- K905666 — M. CAT. BUTYRATE DISC
- K905163 — NITRATE DISK
- K905151 — VANCOMYCIN DISK-5 MCG
- K902595 — CATARRHALIS TEST STRIP
- K902640 — DMAC INDOLE REAGENT
- K901784 — DRYSLIDE, BETA-LACTAMASE
- K902037 — PATHODX PYR KIT
- K901390 — DMAC INDOLE REAGENT
- K896398 — DIFCO OXIDASE DRYSLIDE
- K894221 — ROSCO PYRR
- K890625 — JAMES REAGENT
- K882630 — PRO DISCS
- K882636 — ALN DISCS
- K880694 — B. CAT CONFIRM
- K880950 — PYR/ESCULIN DISK
- K874933 — MUG-INDOLE DISC
- K873509 — IDENTICULT-BL
- K873034 — CONTROLCHEK II(TM)
- K871907 — LD PRESUMPTO QUAD
- K871445 — CONTROLCHEK(TM)
- K870410 — CHROMAGEN TEST FOR GROUP D ENTEROCOCCUS
- K870422 — GEN-PROBE BETA-LACTAMASE TEST KIT
- K870561 — CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION
- K870409 — CHROMAGEN TEST FOR GROUP A STREP
- K870716 — SPOTTEST 10% SODIUM DESOXYCHOLATE
- K870717 — SPOTTEST MICRODASE
- K864244 — GARNERELLA VAGINALIS IDENTIFICATION KIT
- K870449 — SPOTTEST PYR REAGENT
- K863601 — ONPG SOLUTION
- K863216 — NEIS NZY
- K862570 — DISPENS-O-DISC DIFFERENTIATION DISKS PYR
- K861888 — HIPPURATE HYDROLYSIS TEST
- K861889 — D'ALA RAPID TEST
- K861058 — SENSITITRE AUTO ID PLATE, AP70
- K861259 — MACCONKEY W/MUG
- K860156 — NEISSERIASTAT
Data sourced from openFDA. This site is unofficial and independent of the FDA.