Device Classification Name |
Controls For Blood-Gases, (Assayed And Unassayed)
|
510(k) Number |
K022529 |
Device Name |
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 |
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 | 07/31/2002 |
Decision Date | 08/15/2002 |
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
|
|
|