A.P. Total Care, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K991246FRUCTOSAMINE, MODEL FR 106-01December 16, 1999
K991761MAGNESIUM PRODUCT NO'S, 112-01, 112-02September 2, 1999
K991762ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02September 2, 1999
K991664LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01August 19, 1999
K991665HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01August 10, 1999
K991867INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02August 2, 1999
K991866BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04August 2, 1999
K991870ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03July 30, 1999
K991666TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02June 30, 1999
K991663AST/SGOTJune 30, 1999
K991111BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02May 25, 1999
K990980BUN, MODEL BU 104-01May 25, 1999
K990981GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02May 25, 1999
K990978ALBUMIN BCG, MODEL AL 103-01May 25, 1999
K991244TOTAL IRON, MODELS FE 109-01, FE 109-02May 25, 1999
K991109CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02May 25, 1999
K991108CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01May 25, 1999
K991247URIC ACID, MODEL UA112-01May 25, 1999