Product code JTO
- Device name
- Discs, Strips And Reagents, Microorganism Differentiation
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2660
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050352 | IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT | Ameritek Research, LLC | 2005-09-01 |
| K970832 | PYR SWAB | Remel, Inc. | 1997-04-24 |
| K970834 | GRAM SWAB | Remel, Inc. | 1997-04-17 |
| K970833 | INDOLE SWAB | Remel, Inc. | 1997-04-02 |
| K970009 | LYFO(TM) DIFFERENTIAL DISK-BACITRACIN | Microbiologics, Inc. | 1997-02-06 |
| K962966 | IDS RAPID CB PLUS SYSTEM | Innovative Diagnostic Systems, Inc. | 1996-10-08 |
| K961191 | COLISCREEN | Hardy Diagnostics | 1996-06-17 |
| K960996 | M. CAT BUTYRATE DISK | Hardy Diagnostics | 1996-04-18 |
| K955826 | GIBSON ID-M. CAT. | Gibson Laboratories, Inc. | 1996-02-29 |
| K954783 | DRYSLIDE CARTARRHALIS | Difco Laboratories, Inc. | 1996-02-06 |
| K954812 | LYFO(TM) DIFFERIENTAL DISK-PYR | Microbiologics, Inc. | 1995-12-20 |
| K953247 | GIBSON ID A.E. TEST | Gibson Laboratories, Inc. | 1995-11-20 |
| K951889 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | 1995-08-24 |
| K950346 | B-L RED(TM) DISCS | Oxis Intl., Inc. | 1995-05-05 |
| K945883 | LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN | Microbiologics, Inc. | 1995-04-24 |
| K945882 | LYFO(TM) DIFFERENTIAL DISK-BILE | Microbiologics, Inc. | 1995-04-24 |
| K945881 | LYFO(TM) DIFFERENTIAL DISK-STERILE DISK | Microbiologics, Inc. | 1995-04-24 |
| K945880 | LYFO(TM) DIFFERENTIAL DISK-SPS | Microbiologics, Inc. | 1995-04-24 |
| K934130 | SWABZYME OXIDASE | E-Y Laboratories, Inc. | 1994-09-14 |
| K940162 | GONOCHEK II REAGENT TUBES | E-Y Laboratories, Inc. | 1994-09-09 |
| K940161 | B-LACTAMASE REAGENT TUBES | E-Y Laboratories, Inc. | 1994-09-09 |
| K934125 | GONOCHEK-II, MODIFICATION | E-Y Laboratories, Inc. | 1994-09-09 |
| K940124 | EY-20 REAGENT TUBES | E-Y Laboratories, Inc. | 1994-08-26 |
| K940020 | STREP-A-CHEK(TM) REAGENT STRIPS | E-Y Laboratories, Inc. | 1994-08-26 |
| K934129 | STREP-A-CHEK | E-Y Laboratories, Inc. | 1994-08-26 |
| K941111 | STREP-SURE A/E | Clinical Standards Laboratories, Inc. | 1994-08-02 |
| K941016 | DISPENS-O-DISC(TM) NITROCEFIN | Difco Laboratories, Inc. | 1994-06-30 |
| K936021 | BACTICARD STREP | Remel Co. | 1994-05-20 |
| K936034 | SERIM PYLORITEK REAGENT STRIPS | Serim Research Corp. | 1994-04-21 |
| K934986 | BACTICARD E. COLI | Remel Co. | 1994-02-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00816576025121 | N/A | HARDY DIAGNOSTICS | 2024-01-08 |
| 00819398021586 | N/A | HARDY DIAGNOSTICS | 2024-01-08 |
| 00816576029136 | HardyDisk™ | HARDY DIAGNOSTICS | 2023-04-26 |
| 10628429000998 | TestOxidase Reagent (125ml) | PRO-LAB, INCORPORATED | 2022-12-24 |
| 10628429000981 | TestOxidase Reagent (15ml) | PRO-LAB, INCORPORATED | 2022-12-24 |
| 00819398020947 | N/A | HARDY DIAGNOSTICS | 2022-12-07 |
| 00819398026604 | Germ Tube Cryo™ | HARDY DIAGNOSTICS | 2020-08-20 |
| 00816576028870 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-11 |
| 00816576028832 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-10 |
| 00816576028894 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-10 |
| 00816576028856 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-10 |
| 00816576028474 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-10 |
| 00816576028450 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-10 |
| 00816576028412 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-10 |
| 00816576028436 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-10 |
| 00816576028399 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-07 |
| 00816576028368 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-07 |
| 00816576028344 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-07 |
| 00816576028320 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-07 |
| 00816576028276 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-07 |
| 00816576028269 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-07 |
| 10816576028372 | HardyDisk™ | HARDY DIAGNOSTICS | 2020-08-07 |
| 00816576028245 | N/A | HARDY DIAGNOSTICS | 2020-07-09 |
| 00819398026413 | N/A | HARDY DIAGNOSTICS | 2020-06-23 |
| 00819398027083 | N/A | HARDY DIAGNOSTICS | 2020-06-16 |
| 00819398027090 | N/A | HARDY DIAGNOSTICS | 2020-06-16 |
| 00819398027106 | N/A | HARDY DIAGNOSTICS | 2020-06-16 |
| 00819398026895 | N/A | HARDY DIAGNOSTICS | 2020-06-15 |
| 00819398027182 | BlueMount™ | HARDY DIAGNOSTICS | 2020-06-11 |
| 00819398027076 | N/A | HARDY DIAGNOSTICS | 2020-06-10 |