510(k) K780652
- Device
- Hemoglobin Check Solutions, S2100 Osm-2
- Applicant
- THE LONDON CO.
- 510(k) number
- K780652
- Product code
- JKS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-07-27
- Date received
- 1978-04-17
- Regulation
- 862.3220
- Classification name
- Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3002721930
- 3010419931
- 3011353843
- 3004415095
- 1217183
- 3014579161
- 3016678045
- 3023162659
- 3000126629
- 3016674095
- 1219029
- 3027256461
- 3009831876
- 3019388613
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JKS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K951485 | AVOXIMETER 4000 | A-Vox Systems, Inc. | 1995-11-06 |
| K863825 | CO-OXIMETER SOLUTIONS | D.R.G. Scientific Industries | 1986-11-24 |
| K862253 | IL 482 CO-OXIMETER | Instrumentation Laboratory CO | 1986-07-29 |
| K853990 | OSM3 HEMOXIMETER | Radiometer America, Inc. | 1985-12-30 |
| K833693 | TEE ADAPTER 9890-FLUSH WINDING 282 | Shaban Mfg. Co. | 1983-12-30 |
| K833211 | BILE SALTS MIXTURE | Acumedia Manufacturers, Inc. | 1983-10-27 |
| K832066 | CONTROL 282 | Bio-Nustics, Inc. | 1983-09-29 |