| Device Classification Name |
Chromatography(Gas), Clinical Use
|
| 510(k) Number |
K791138 |
| Device Name |
5880 SERIES OF GAS CHROMATOGRAPHS |
| Applicant |
| Hewlett-Packard Co. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Hewlett-Packard Co. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Regulation Number | 862.2250 |
| Classification Product Code |
|
| Date Received | 06/18/1979 |
| Decision Date | 07/24/1979 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Clinical Chemistry
|
| 510k Review Panel |
Toxicology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|