Identicult-Bl
FDA 510(k) K873509 · Scott Laboratories, Inc.
510(k) numberK873509
Submission
- Device name
- Identicult-Bl
- Applicant
- Scott Laboratories, Inc.
West Warwick, RI, US - Received
- August 31, 1987
- Decision date
- October 15, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTO – Discs, Strips And Reagents, Microorganism Differentiation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JTO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050352 | In-Vitro Diagnostic Vaginitis Test KitJTO · Traditional | Ameritek Research, LLC | 09/01/2005SE |
| K970832 | Pyr SwabJTO · Traditional | Remel, Inc. | 04/24/1997SE |
| K970834 | Gram SwabJTO · Traditional | Remel, Inc. | 04/17/1997SE |
| K970833 | Indole SwabJTO · Traditional | Remel, Inc. | 04/02/1997SE |
| K970009 | Lyfo(Tm) Differential Disk-BacitracinJTO · Traditional | Microbiologics, Inc. | 02/06/1997SE |
| K962966 | Ids Rapid CB Plus SystemJTO · Traditional | Innovative Diagnostic Systems, Inc. | 10/08/1996SE |
| K961191 | ColiscreenJTO · Traditional | Hardy Diagnostics | 06/17/1996SE |
| K960996 | M. Cat Butyrate DiskJTO · Traditional | Hardy Diagnostics | 04/18/1996SE |
| K955826 | Gibson Id-M. Cat.JTO · Traditional | Gibson Laboratories, Inc. | 02/29/1996SE |
| K954783 | Dryslide CartarrhalisJTO · Traditional | Difco Laboratories, Inc. | 02/06/1996SE |
More from Difco Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880694 | B. Cat ConfirmJTO · Traditional | 06/16/1988SE |
| K874933 | Mug-Indole DiscJTO · Traditional | 01/05/1988SE |
| K874662 | Myco-Fluor Reagent a & BJTS · Traditional | 11/25/1987SE |
| K871238 | AnabagKZJ · Traditional | 04/03/1987SE |
| K863025 | Sero-Stat R II Staphylococcus TestLHT · Traditional | 09/15/1986SE |
| K852869 | Selecticult-ChlamydiaLKH · Traditional | 09/19/1985SE |
| K852832 | Identicult-NeisseriaJTO · Traditional | 07/19/1985SE |
| K852666 | Identicult-AeJTO · Traditional | 07/15/1985SE |
| K841680 | Scott Selecticult-Hsv Isolation &GQL · Traditional | 10/30/1984SE |
| K811098 | Sero-Stat Staphylococcus TestJWX · Traditional | 05/05/1981SE |
Questions and answers
When was Identicult-Bl cleared by the FDA?
Identicult-Bl (K873509) received a 510(k) decision of Substantially Equivalent on October 15, 1987, 45 days after the submission was received.
What is the product code of K873509?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.