Hemoglobin Check Solutions, S2100 OSM-2
FDA 510(k) K780652 · The London Co.
510(k) numberK780652
Submission
- Device name
- Hemoglobin Check Solutions, S2100 OSM-2
- Applicant
- The London Co.
Mchenry, IL, US - Received
- April 17, 1978
- Decision date
- July 27, 1978
- 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 |
| K833211 | Bile Salts MixtureJKS · Traditional | Acumedia Manufacturers, Inc. | 10/27/1983SE |
| K832066 | Control 282JKS · Traditional | Bio-Nustics, Inc. | 09/29/1983SE |
More from Bio-Nustics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K802846 | TCM202 TCPO2 & TCM204 TCPO2/PO2 Rec. Sy.KLK · Traditional | 12/17/1980SE |
| K801848 | ICA1 Ionized Calcium AnalyzerJFP · Traditional | 10/31/1980SE |
| K800224 | Radiometer Acid Base LABORATORY-ABL-3CHL · Traditional | 02/22/1980SE |
| K771444 | Qualicheck TMJJS · Traditional | 08/16/1977SE |
| K771263 | Radiomhter OSM-2 HemoximeterGHS · Traditional | 08/03/1977SE |
| K760229 | Acid Base System, Radiometer AutomatedCHL · Traditional | 08/26/1976SE |
Questions and answers
When was Hemoglobin Check Solutions, S2100 OSM-2 cleared by the FDA?
Hemoglobin Check Solutions, S2100 OSM-2 (K780652) received a 510(k) decision of Substantially Equivalent on July 27, 1978, 101 days after the submission was received.
What is the product code of K780652?
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.