Medical Device Manufacturer · US , Bridgeport , CT

A.P. Total Care, Inc. - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 1999
18
Total
18
Cleared
0
Denied

FDA 510(k) Regulatory Record - A.P. Total Care, Inc. Chemistry

18 devices
1-18 of 18
Cleared Dec 16, 1999
FRUCTOSAMINE, MODEL FR 106-01
K991246 · LCP
Chemistry · 248d
Cleared Sep 02, 1999
MAGNESIUM PRODUCT NO'S, 112-01, 112-02
K991761 · JGJ
Chemistry · 101d
Cleared Sep 02, 1999
ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02
K991762 · CJE
Chemistry · 101d
Cleared Aug 19, 1999
LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
K991664 · LBS
Chemistry · 97d
Cleared Aug 10, 1999
HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
K991665 · LBS
Chemistry · 88d
Cleared Aug 02, 1999
BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04
K991866 · CIG
Chemistry · 62d
Cleared Aug 02, 1999
INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02
K991867 · CEO
Chemistry · 62d
Cleared Jul 30, 1999
ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
K991870 · CGZ
Chemistry · 59d
Cleared Jun 30, 1999
AST/SGOT
K991663 · CIT
Chemistry · 47d
Cleared Jun 30, 1999
TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
K991666 · JMO
Chemistry · 47d
Cleared May 25, 1999
ALBUMIN BCG, MODEL AL 103-01
K990978 · CJW
Chemistry · 63d
Cleared May 25, 1999
BUN, MODEL BU 104-01
K990980 · CDQ
Chemistry · 63d
Cleared May 25, 1999
GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL...
K990981 · CFR
Chemistry · 63d
Cleared May 25, 1999
CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01
K991108 · KHS
Chemistry · 54d
Cleared May 25, 1999
CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02
K991109 · CGX
Chemistry · 54d
Cleared May 25, 1999
BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO....
K991111 · CIC
Chemistry · 54d
Cleared May 25, 1999
TOTAL IRON, MODELS FE 109-01, FE 109-02
K991244 · JMO
Chemistry · 43d
Cleared May 25, 1999
URIC ACID, MODEL UA112-01
K991247 · KNK
Chemistry · 43d
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