| Device Classification Name |
Antisera, Fluorescent, B. Parapertussis
|
| 510(k) Number |
K761019 |
| Device Name |
PIPETTER-DILUTER (MODEL 273) |
| Applicant |
| Beckman Instruments, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Beckman Instruments, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Regulation Number | 866.3065 |
| Classification Product Code |
|
| Date Received | 11/11/1976 |
| Decision Date | 11/16/1976 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Microbiology
|
| 510k Review Panel |
Clinical Chemistry
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|