Device Classification Name |
culture media, antimicrobial susceptibility test, excluding mueller hinton agar
|
510(k) Number |
K892928 |
Device Name |
HAEMOPHILUS TEST MEDIUM (AGAR) |
Applicant |
REMEL CO. |
12076 SANTA FE DR. |
LENEXA,
KS
66215
|
|
Applicant Contact |
BRENDA TEPLY |
Correspondent |
REMEL CO. |
12076 SANTA FE DR. |
LENEXA,
KS
66215
|
|
Correspondent Contact |
BRENDA TEPLY |
Regulation Number | 866.1700
|
Classification Product Code |
|
Date Received | 04/21/1989 |
Decision Date | 06/13/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|