Device Classification Name |
Single (Specified) Analyte Controls (Assayed And Unassayed)
|
510(k) Number |
K984323 |
Device Name |
ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 |
Applicant |
BIO-RAD |
9500 JERONIMO RD. |
IRVINE,
CA
92618
|
|
Applicant Contact |
ELIZABETH PLATT |
Correspondent |
BIO-RAD |
9500 JERONIMO RD. |
IRVINE,
CA
92618
|
|
Correspondent Contact |
ELIZABETH PLATT |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 12/03/1998 |
Decision Date | 12/15/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|