FDA 510(k) Applications Submitted by AMERICAN LABORATORY PRODUCTS CO., LTD.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K970932 |
02/20/1997 |
ORGENTEC MICRO-ALBUMIN EIA ASSAY |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
| K972190 |
05/19/1997 |
THYROGLOBULIN ASSAY SYSTEM |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
| K962052 |
05/28/1996 |
ORGENTEC ABTI-SS-BB(LA) ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
| K962053 |
05/28/1996 |
ORGENTEC ANTI-JO-1 ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
| K962054 |
05/28/1996 |
ORGENTEC ANTI-SS-A(RO) ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
| K962055 |
05/28/1996 |
ORGENTEC ANTI-SCL 70 ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
| K962057 |
05/28/1996 |
ORGENTEC ANTI-RNP/SM ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
| K962062 |
05/28/1996 |
ORGENTEC ANTI-SM ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
| K962469 |
06/25/1996 |
ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
| K962926 |
07/29/1996 |
ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
| K963911 |
09/30/1996 |
ALPCO/MERCODIA INSULIN ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
| K955449 |
11/29/1995 |
ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
| K974701 |
12/08/1997 |
ORGENTEC ANTI-MPO (P-ANCA) ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
| K974702 |
12/08/1997 |
ORGENTEC ANTI-PR3 (C-ANCA) ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
| K011201 |
04/19/2001 |
ALPCO MILENIA ANTI-TPO ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
| K011415 |
05/08/2001 |
ALPCO MILENIA ANTI-TG EIA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
| K012576 |
08/09/2001 |
CIC-C1Q EIA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
| K955561 |
12/06/1995 |
BUHLMANN VITAMIN B6 REA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
|
|
