Reagents for Determ. CO2 in Human Serum
FDA 510(k) K800681 · Diagnostic Solutions, Inc.
510(k) numberK800681
Submission
- Device name
- Reagents for Determ. CO2 in Human Serum
- Applicant
- Diagnostic Solutions, Inc.
Mchenry, IL, US - Received
- March 26, 1980
- Decision date
- May 30, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KMS – Phenolphthalein Colorimetry, Carbon-Dioxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1160
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KMS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K872886 | Carbon DioxideKMS · Traditional | Catachem, Inc. | 08/13/1987SE |
| K870025 | Amresco Flow Pac Carbon Dioxide (CO2) ReagentsKMS · Traditional | American Research Products Co. | 03/13/1987SE |
| K802162 | CO2 Color Reagent & CO2 Sample DiluentKMS · Traditional | Panmed, Inc. | 10/10/1980SE |
| K780506 | Carbon Dioxide ReagentsKMS · Traditional | Gamma Enterprises, Inc. | 05/03/1978SE |
More from Gamma Enterprises, 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 |
| 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 |
| K800686 | Reagent for Determ. Direct BilirubinCIG · Traditional | 05/28/1980SE |
Questions and answers
When was Reagents for Determ. CO2 in Human Serum cleared by the FDA?
Reagents for Determ. CO2 in Human Serum (K800681) received a 510(k) decision of Substantially Equivalent on May 30, 1980, 65 days after the submission was received.
What is the product code of K800681?
The FDA product code is KMS – Phenolphthalein Colorimetry, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.