Device Classification Name |
controls for blood-gases, (assayed and unassayed)
|
510(k) Number |
K002536 |
Device Name |
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) |
Applicant |
BIO-RAD |
9500 JERONIMO RD. |
IRVINE,
CA
92618 -2017
|
|
Applicant Contact |
ELIZABETH PLATT |
Correspondent |
BIO-RAD |
9500 JERONIMO RD. |
IRVINE,
CA
92618 -2017
|
|
Correspondent Contact |
ELIZABETH PLATT |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 08/16/2000 |
Decision Date | 08/30/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|