Mywasher 5
FDA 510(k) K853285 · Scientific Sales Intl., Inc.
510(k) numberK853285
Submission
- Device name
- Mywasher 5
- Applicant
- Scientific Sales Intl., Inc.
Kalamazoo, MI, US - Received
- August 5, 1985
- Decision date
- October 4, 1985
- 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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|---|---|---|---|
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| 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 |
| K864249 | Normal Saline SterileLIB · Traditional | Mds Laboratories, Inc. | 03/31/1987SE |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K953677 | Lighted Flexguide (Modification)BSR · Traditional | 08/25/1995SE |
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| K860996 | Sanassay Ic TestDAK · Traditional | 03/30/1987SE |
| K862087 | Santest 1APLKL · Traditional | 12/03/1986SE |
| K861336 | Iap Plate TestLKL · Traditional | 04/25/1986SE |
| K853284 | Myreader 7JJQ · Traditional | 10/04/1985SE |
| K853380 | SPR 2 AutodiluterJTC · Traditional | 09/12/1985SE |
| K853379 | Plate IncubatorJTQ · Traditional | 09/03/1985SE |
| K833022 | Air Uterine Displacer-Aud 120CCX · Traditional | 10/14/1983SE |
| K802416 | Salem/Resce Intubation GuideBSR · Traditional | 10/23/1980SE |
Questions and answers
When was Mywasher 5 cleared by the FDA?
Mywasher 5 (K853285) received a 510(k) decision of Substantially Equivalent on October 4, 1985, 60 days after the submission was received.
What is the product code of K853285?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.