Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K822699 |
Device Name |
GLUCOSCAN METER MODEL II |
Applicant |
LIFESCAN, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
LIFESCAN, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 09/07/1982 |
Decision Date | 11/05/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|