Pseudo-Palette TM
FDA 510(k) K790992 · Micro-Palettes, Inc.
510(k) numberK790992
Submission
- Device name
- Pseudo-Palette TM
- Applicant
- Micro-Palettes, Inc.
Mchenry, IL, US - Received
- May 29, 1979
- Decision date
- June 22, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSW – Kit, Identification, Glucose Nonfermenter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JSW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K922768 | Rapid NFT, ModificationJSW · Traditional | Biomerieux Vitek, Inc. | 10/14/1992SE |
| K900517 | Rapid NF SystemJSW · Traditional | Innovative Diagnostic Systems, Inc. | 03/13/1990SE |
| K870769 | Austin Nonfermenter KitJSW · Traditional | Austin Biological Laboratories | 04/03/1987SE |
| K772112 | Non-Fermenter SystemJSW · Traditional | Corning Medical & Scientific | 11/17/1977SE |
| K770745 | Panel, GNF, Micro-IdJSW · Traditional | Micro-Media Systems, Inc. | 06/23/1977SE |
More from Micro-Media Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K790991 | Yeast-Palette TMJXB · Traditional | 06/22/1979SE |
Questions and answers
When was Pseudo-Palette TM cleared by the FDA?
Pseudo-Palette TM (K790992) received a 510(k) decision of Substantially Equivalent on June 22, 1979, 24 days after the submission was received.
What is the product code of K790992?
The FDA product code is JSW – Kit, Identification, Glucose Nonfermenter, a Class I (low risk) device regulated under 21 CFR 866.2660.