Co-Oximeter Solutions
FDA 510(k) K863825 · D.R.G. Scientific Industries
510(k) numberK863825
Submission
- Device name
- Co-Oximeter Solutions
- Applicant
- D.R.G. Scientific Industries
East Boston, MA, US - Received
- September 30, 1986
- Decision date
- November 24, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JKS – Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3220
- Specialty
- Clinical Toxicology
Other 510(k)s with product code JKS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K951485 | Avoximeter 4000JKS · Traditional | A-Vox Systems, Inc. | 11/06/1995SE |
| K862253 | Il 482 Co-OximeterJKS · Traditional | Instrumentation Laboratory CO | 07/29/1986SE |
| K853990 | OSM3 HemoximeterJKS · Traditional | Radiometer America, Inc. | 12/30/1985SE |
| K833693 | Tee Adapter 9890-FLUSH Winding 282JKS · Traditional | Shaban Mfg. Co. | 12/30/1983SE |
| K833211 | Bile Salts MixtureJKS · Traditional | Acumedia Manufacturers, Inc. | 10/27/1983SE |
| K832066 | Control 282JKS · Traditional | Bio-Nustics, Inc. | 09/29/1983SE |
| K780652 | Hemoglobin Check Solutions, S2100 OSM-2JKS · Traditional | The London Co. | 07/27/1978SE |
More from The London Co.
| 510(k) | Device | Decision |
|---|---|---|
| K892329 | Osmometer Standard SolutionsJIT · Traditional | 10/31/1989SE |
| K870889 | Acid Fuchsin SolutionsFKQ · Traditional | 07/08/1987SE |
| K863880 | Blood Gases/ PO2, PCO2 and Blood PH Analysis Prod.CHL · Traditional | 11/24/1986SE |
| K863824 | Solution/Test Standard/Conduct. Dialy.&Mult.Solut.FKH · Traditional | 10/24/1986SE |
Questions and answers
When was Co-Oximeter Solutions cleared by the FDA?
Co-Oximeter Solutions (K863825) received a 510(k) decision of Substantially Equivalent on November 24, 1986, 55 days after the submission was received.
What is the product code of K863825?
The FDA product code is JKS – Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide, a Class I (low risk) device regulated under 21 CFR 862.3220.