JTO — Discs, Strips And Reagents, Microorganism Differentiation Class I
FDA product code JTO covers "Discs, Strips And Reagents, Microorganism Differentiation", a Class I medical device regulated under 21 CFR 866.2660. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JTO
- Device Class
- Class I
- Regulation Number
- 866.2660
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K050352 | ameritek research | IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT | September 1, 2005 |
| K970832 | remel | PYR SWAB | April 24, 1997 |
| K970834 | remel | GRAM SWAB | April 17, 1997 |
| K970833 | remel | INDOLE SWAB | April 2, 1997 |
| K970009 | microbiologics | LYFO(TM) DIFFERENTIAL DISK-BACITRACIN | February 6, 1997 |
| K962966 | innovative diagnostic systems | IDS RAPID CB PLUS SYSTEM | October 8, 1996 |
| K961191 | hardy diagnostics | COLISCREEN | June 17, 1996 |
| K960996 | hardy diagnostics | M. CAT BUTYRATE DISK | April 18, 1996 |
| K955826 | gibson laboratories | GIBSON ID-M. CAT. | February 29, 1996 |
| K954783 | difco laboratories | DRYSLIDE CARTARRHALIS | February 6, 1996 |
| K954812 | microbiologics | LYFO(TM) DIFFERIENTAL DISK-PYR | December 20, 1995 |
| K953247 | gibson laboratories | GIBSON ID A.E. TEST | November 20, 1995 |
| K951889 | microbiologics | LYFO(TM) DIFFERENTIAL DISK | August 24, 1995 |
| K950346 | oxis intl | B-L RED(TM) DISCS | May 5, 1995 |
| K945880 | microbiologics | LYFO(TM) DIFFERENTIAL DISK-SPS | April 24, 1995 |
| K945881 | microbiologics | LYFO(TM) DIFFERENTIAL DISK-STERILE DISK | April 24, 1995 |
| K945883 | microbiologics | LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN | April 24, 1995 |
| K945882 | microbiologics | LYFO(TM) DIFFERENTIAL DISK-BILE | April 24, 1995 |
| K934130 | e-y laboratories | SWABZYME OXIDASE | September 14, 1994 |
| K934125 | e-y laboratories | GONOCHEK-II, MODIFICATION | September 9, 1994 |