Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K864224 |
FOIA Releasable 510(k) |
K864224
|
Device Name |
ABBOTT SPECTRUM GLUCOSE REAGENT |
Applicant |
ABBOTT LABORATORIES |
1921 HURD DR. |
P.O.BOX 152020 |
IRVING,
TX
75015 -2020
|
|
Applicant Contact |
KEITH MINTER |
Correspondent |
ABBOTT LABORATORIES |
1921 HURD DR. |
P.O.BOX 152020 |
IRVING,
TX
75015 -2020
|
|
Correspondent Contact |
KEITH MINTER |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 10/28/1986 |
Decision Date | 01/05/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|