CO2 Color Reagent & CO2 Sample Diluent
FDA 510(k) K802162 · Panmed, Inc.
510(k) numberK802162
Submission
- Device name
- CO2 Color Reagent & CO2 Sample Diluent
- Applicant
- Panmed, Inc.
Mchenry, IL, US - Received
- September 8, 1980
- Decision date
- October 10, 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 |
| K800681 | Reagents for Determ. CO2 in Human SerumKMS · Traditional | Diagnostic Solutions, Inc. | 05/30/1980SE |
| K780506 | Carbon Dioxide ReagentsKMS · Traditional | Gamma Enterprises, Inc. | 05/03/1978SE |
More from Gamma Enterprises, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K852767 | Erythocyte CreatineJLA · Traditional | 11/13/1986SE |
| K820642 | Sickle-CheckGHM · Traditional | 04/14/1982SE |
| K802164 | 8-HYDROXYQUINOLINE, Cresolphthalein Com.CIC · Traditional | 10/10/1980SE |
| K802163 | Chloride Color & Chloride Sample DiluentCHJ · Traditional | 10/10/1980SE |
| K802161 | Biuret Reagent & Total Protein Blank SolCEK · Traditional | 10/10/1980SE |
| K802160 | Bun Color Reagent & Bun Acid UsedCDW · Traditional | 10/10/1980SE |
| K802159 | Ammonium Molybdate Inorganic PhosphorusCEO · Traditional | 10/10/1980SE |
| K802158 | Postassium Buffer Sol. & Wash SolutionCEM · Traditional | 10/10/1980SE |
| K802157 | BCG Reagent Serum Albumin W/TechniconCIX · Traditional | 10/10/1980SE |
| K802156 | Reagents Serum Creatine Using TechiconCGX · Traditional | 10/10/1980SE |
Questions and answers
When was CO2 Color Reagent & CO2 Sample Diluent cleared by the FDA?
CO2 Color Reagent & CO2 Sample Diluent (K802162) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 32 days after the submission was received.
What is the product code of K802162?
The FDA product code is KMS – Phenolphthalein Colorimetry, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.