Saline Solution
FDA 510(k) K820213 · Dms Laboratories
510(k) numberK820213
Submission
- Device name
- Saline Solution
- Applicant
- Dms Laboratories
Mchenry, IL, US - Received
- January 26, 1982
- Decision date
- February 12, 1982
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K831187 | TRPJTO · Traditional | 05/09/1983SE |
| K831186 | Rapid NFTJSN · Traditional | 05/09/1983SE |
| K830437 | CHSJSC · Traditional | 03/17/1983SE |
| K823102 | Agar PJSJ · Traditional | 12/03/1982SE |
| K821038 | Fast Violet BJTS · Traditional | 05/27/1982SE |
| K813613 | Rapid CHJTO · Traditional | 02/22/1982SE |
| K813612 | Rapid ZymeJTO · Traditional | 02/22/1982SE |
| K820212 | OxiJTO · Traditional | 02/12/1982SE |
| K820211 | NinhydrinJTO · Traditional | 02/12/1982SE |
| K820210 | IndJTO · Traditional | 02/12/1982SE |
Questions and answers
When was Saline Solution cleared by the FDA?
Saline Solution (K820213) received a 510(k) decision of Substantially Equivalent on February 12, 1982, 17 days after the submission was received.
What is the product code of K820213?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.