| Device Classification Name |
Counter (Beta, Gamma) For Clinical Use
|
| 510(k) Number |
K862206 |
| Device Name |
TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER |
| Applicant |
| Micromedic Systems |
| 102 Witmer Rd. |
|
Horsham,
PA
19044
|
|
| Applicant Contact |
DEBORAH L LINDEMUTH |
| Correspondent |
| Micromedic Systems |
| 102 Witmer Rd. |
|
Horsham,
PA
19044
|
|
| Correspondent Contact |
DEBORAH L LINDEMUTH |
| Regulation Number | 862.2320 |
| Classification Product Code |
|
| Date Received | 06/10/1986 |
| Decision Date | 08/04/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Clinical Chemistry
|
| 510k Review Panel |
Clinical Chemistry
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|