FDA 510(k) Applications Submitted by LUIS P LEON
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K990978 |
03/23/1999 |
ALBUMIN BCG, MODEL AL 103-01 |
A.P. TOTAL CARE, INC. |
K990980 |
03/23/1999 |
BUN, MODEL BU 104-01 |
A.P. TOTAL CARE, INC. |
K990981 |
03/23/1999 |
GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02 |
A.P. TOTAL CARE, INC. |
K991108 |
04/01/1999 |
CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01 |
A.P. TOTAL CARE, INC. |
K991109 |
04/01/1999 |
CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02 |
A.P. TOTAL CARE, INC. |
K991111 |
04/01/1999 |
BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02 |
A.P. TOTAL CARE, INC. |
K991244 |
04/12/1999 |
TOTAL IRON, MODELS FE 109-01, FE 109-02 |
A.P. TOTAL CARE, INC. |
K991246 |
04/12/1999 |
FRUCTOSAMINE, MODEL FR 106-01 |
A.P. TOTAL CARE, INC. |
K991247 |
04/12/1999 |
URIC ACID, MODEL UA112-01 |
A.P. TOTAL CARE, INC. |
K991663 |
05/14/1999 |
AST/SGOT |
A.P. TOTAL CARE, INC. |
K991664 |
05/14/1999 |
LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 |
A.P. TOTAL CARE, INC. |
K991665 |
05/14/1999 |
HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 |
A.P. TOTAL CARE, INC. |
K991666 |
05/14/1999 |
TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 |
A.P. TOTAL CARE, INC. |
K991761 |
05/24/1999 |
MAGNESIUM PRODUCT NO'S, 112-01, 112-02 |
A.P. TOTAL CARE, INC. |
K991762 |
05/24/1999 |
ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 |
A.P. TOTAL CARE, INC. |
K991866 |
06/01/1999 |
BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 |
A.P. TOTAL CARE, INC. |
K991867 |
06/01/1999 |
INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 |
A.P. TOTAL CARE, INC. |
K991870 |
06/01/1999 |
ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03 |
A.P. TOTAL CARE, INC. |
K062503 |
08/25/2006 |
CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT |
CATACHEM, INC. |
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