Device Classification Name |
kit, quality control for culture media
|
510(k) Number |
K861022 |
Device Name |
KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS |
Applicant |
MICRO-BIO-LOGICS |
217 OSSEO AVENUE NORTH |
ST. CLOUD,
MN
56301
|
|
Applicant Contact |
GERALD TJERNAGEL |
Correspondent |
MICRO-BIO-LOGICS |
217 OSSEO AVENUE NORTH |
ST. CLOUD,
MN
56301
|
|
Correspondent Contact |
GERALD TJERNAGEL |
Regulation Number | 866.2480
|
Classification Product Code |
|
Date Received | 03/18/1986 |
Decision Date | 04/04/1986 |
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
|
|
|