Bile Salts Mixture
FDA 510(k) K833211 · Acumedia Manufacturers, Inc.
510(k) numberK833211
Submission
- Device name
- Bile Salts Mixture
- Applicant
- Acumedia Manufacturers, Inc.
Mchenry, IL, US - Received
- September 19, 1983
- Decision date
- October 27, 1983
- 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 |
| K863825 | Co-Oximeter SolutionsJKS · Traditional | D.R.G. Scientific Industries | 11/24/1986SE |
| 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 |
| 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 |
|---|---|---|
| K881579 | Amies Transport Medium W/O CharcoalJSN · Traditional | 04/18/1988SE |
| K881578 | StreptoselJSJ · Traditional | 04/18/1988SE |
| K881577 | Modified Selective Streptococcus AgarJSI · Traditional | 04/18/1988SE |
| K881576 | Selenite BrothJSI · Traditional | 04/18/1988SE |
| K881575 | Selective Streptococcus AgarJSI · Traditional | 04/18/1988SE |
| K881574 | W-L Differential MediumJSJ · Traditional | 04/18/1988SE |
| K881573 | Phytone Yeast Extract AgarJSJ · Traditional | 04/18/1988SE |
| K881572 | XL Agar BaseJSI · Traditional | 04/18/1988SE |
| K881571 | Ym BrothJSJ · Traditional | 04/18/1988SE |
| K881570 | Sabouraud Maltose AgarJSJ · Traditional | 04/18/1988SE |
Questions and answers
When was Bile Salts Mixture cleared by the FDA?
Bile Salts Mixture (K833211) received a 510(k) decision of Substantially Equivalent on October 27, 1983, 38 days after the submission was received.
What is the product code of K833211?
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.