Device Classification Name |
Dna-Probe, Reagents, Streptococcal
|
510(k) Number |
K974572 |
Device Name |
GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 |
Applicant |
CHUGAI PHARMACEUTICALS CO., LTD. |
10210 GENETIC CENTER DR. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
GERALD H SCHELL |
Correspondent |
CHUGAI PHARMACEUTICALS CO., LTD. |
10210 GENETIC CENTER DR. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
GERALD H SCHELL |
Regulation Number | 866.3740
|
Classification Product Code |
|
Date Received | 12/05/1997 |
Decision Date | 09/24/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|