Device Classification Name |
Reagent, Borrelia Serological Reagent
|
510(k) Number |
K911590 |
Device Name |
IMMUNOWELL BORRELIA (LYME)TEST |
Applicant |
GENERAL BIOMETRICS, INC. |
15222 Avenue of Science |
Suite A |
San DIego,
CA
92128
|
|
Applicant Contact |
BRYAN L KIEHL |
Correspondent |
GENERAL BIOMETRICS, INC. |
15222 Avenue of Science |
Suite A |
San DIego,
CA
92128
|
|
Correspondent Contact |
BRYAN L KIEHL |
Regulation Number | 866.3830
|
Classification Product Code |
|
Date Received | 04/09/1991 |
Decision Date | 12/20/1991 |
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
|
|
|