Normal Saline Sterile
FDA 510(k) K864249 · Mds Laboratories, Inc.
510(k) numberK864249
Submission
- Device name
- Normal Saline Sterile
- Applicant
- Mds Laboratories, Inc.
L5j 2m4, CA - Received
- October 28, 1986
- Decision date
- March 31, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIB – Device, General Purpose, Microbiology, Diagnostic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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|---|---|---|---|
| K023677 | Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-Bv)LIB · Traditional | Osmetech | 01/29/2003SE |
| K920416 | Supplementary Reagents for Enzygnost/TmbLIB · Traditional | Behring Diagnostics, Inc. | 04/08/1992SE |
| K912558 | Gull ElisawareLIB · Traditional | Gull Laboratories, Inc. | 09/16/1991SE |
| K872273 | Corning Easy Wash Elisa PlatesLIB · Traditional | Corning Medical & Scientific | 07/07/1987SE |
| K871559 | Cell LifterLIB · Traditional | Corning Costar Corp. | 05/15/1987SE |
| K863789 | Corning Elisa PlatesLIB · Traditional | Corning Medical & Scientific | 10/03/1986SE |
| K862112 | Microscope SlidesLIB · Traditional | Abco Dealers, Inc. | 06/13/1986SE |
| K854604 | Auto MashLIB · Traditional | Dynatech Corp. | 12/06/1985SE |
| K854603 | Multi Mash 2000LIB · Traditional | Dynatech Corp. | 12/06/1985SE |
| K854602 | Mini Mash 2000LIB · Traditional | Dynatech Corp. | 12/06/1985SE |
More from Dynatech Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K864256 | Tryptone Water (1%)JSF · Traditional | 03/31/1987SE |
| K864255 | Trypticase Soy BrothJSG · Traditional | 03/31/1987SE |
| K864254 | Thioglycollate BrothJSG · Traditional | 03/31/1987SE |
| K864253 | Thayer Martin AgarJTY · Traditional | 03/31/1987SE |
| K864252 | Thayer-Martin JembecJTY · Traditional | 03/31/1987SE |
| K864251 | Selenite F. BrothJSJ · Traditional | 03/31/1987SE |
| K864250 | Sabouraud Dextrose AgarJSJ · Traditional | 03/31/1987SE |
| K864248 | Mueller Hinton Agar - SupplementedJTZ · Traditional | 03/31/1987SE |
| K864247 | Mueller Hinton Agar with 5% Sheep BloodJTZ · Traditional | 03/31/1987SE |
| K864246 | Mueller Hinton Agar LargeJTZ · Traditional | 03/31/1987SE |
Questions and answers
When was Normal Saline Sterile cleared by the FDA?
Normal Saline Sterile (K864249) received a 510(k) decision of Substantially Equivalent on March 31, 1987, 154 days after the submission was received.
What is the product code of K864249?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.