Sensititre Auto Id Plate, AP70
FDA 510(k) K861058 · Gibco Laboratories Life Technologies, Inc.
510(k) numberK861058
Submission
- Device name
- Sensititre Auto Id Plate, AP70
- Applicant
- Gibco Laboratories Life Technologies, Inc.
Andover, MA, US - Received
- March 19, 1986
- Decision date
- May 20, 1986
- 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
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| 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 |
|---|---|---|
| K871855 | Sorbitol Macconkey (Smac) Agar, Dri & Pre-FormJSH · Traditional | 05/26/1987SE |
| K871541 | Martin-Lewis Agar W/Reduced Vancomycin C0226JTY · Traditional | 04/29/1987SE |
| K870134 | Mcbride Listeria Agar W/Cycloheximide, Dri & PreJSJ · Traditional | 02/04/1987SE |
| K864755 | Pseudomonas Cepacia Selective Agar, Dri & Pre-FormJSJ · Traditional | 01/05/1987SE |
| K864014 | Lombard Dowell Agar BaseKZI · Traditional | 10/29/1986SE |
| K863821 | Mueller Hinton Agar W/4%NACL and OxacillinJTZ · Traditional | 10/09/1986SE |
| K863820 | Dri-Form: Gbna Listeria Medium No. M22300JSJ · Traditional | 10/08/1986SE |
| K863289 | CDC Anaerobic Agar W/Sheep Blood, Kana-&VancomycinJSJ · Traditional | 09/03/1986SE |
| K862425 | Macconkey Agar W/Mug, Dri-Form and Pre-FormJSI · Traditional | 07/02/1986SE |
| K861734 | Regan-Lowe AgarJSJ · Traditional | 05/16/1986SE |
Questions and answers
When was Sensititre Auto Id Plate, AP70 cleared by the FDA?
Sensititre Auto Id Plate, AP70 (K861058) received a 510(k) decision of Substantially Equivalent on May 20, 1986, 62 days after the submission was received.
What is the product code of K861058?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.