Smac Replacement Reagents, Wetting Agent
FDA 510(k) K800670 · Diagnostic Solutions, Inc.
510(k) numberK800670
Submission
- Device name
- Smac Replacement Reagents, Wetting Agent
- Applicant
- Diagnostic Solutions, Inc.
Mchenry, IL, US - Received
- March 26, 1980
- Decision date
- April 16, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Diagnostic Solutions, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K934892 | Relief Plus One Reagent Strip ModificationCGA · Traditional | 01/11/1994SE |
| K924398 | Uni-Check Reagent StripCGA · Traditional | 12/23/1992SE |
| K921825 | Quick-Check II Reagent StripCGA · Traditional | 08/18/1992SE |
| K800689 | Reagent for Determ. Glutamic-Pyruvic-CKA · Traditional | 05/30/1980SE |
| K800681 | Reagents for Determ. CO2 in Human SerumKMS · Traditional | 05/30/1980SE |
| K800692 | Reagent for Determ. Potassium/In HumanCEM · Traditional | 05/28/1980SE |
| K800691 | Reagent for Determ. Lactate/DehydrogenasCFJ · Traditional | 05/28/1980SE |
| K800690 | Reagent for Determ. Inorganic/PhosphorusCEO · Traditional | 05/28/1980SE |
| K800688 | Reagent for Determ. Glutamic-OxaloaceticCIT · Traditional | 05/28/1980SE |
| K800687 | Reagent for Determ. Glucose in H/SerumCGA · Traditional | 05/28/1980SE |
Questions and answers
When was Smac Replacement Reagents, Wetting Agent cleared by the FDA?
Smac Replacement Reagents, Wetting Agent (K800670) received a 510(k) decision of Substantially Equivalent on April 16, 1980, 21 days after the submission was received.