Electrophoresis Corp. of America - FDA 510(k) Cleared Devices
27
Total
27
Cleared
0
Denied
20 devices
Cleared
Nov 26, 1980
GENERAL PROCEDURE AGAROSE FILM
Chemistry
55d
Cleared
Jan 29, 1980
AGAROSE BARBITAL BUFFER
Chemistry
50d
Cleared
Jan 29, 1980
ALKALINE PHOSPHATASE MARKER
Chemistry
50d
Cleared
Jan 29, 1980
ALKALINE PHOSPHATASE REAGENT
Chemistry
50d
Cleared
Jan 29, 1980
AGAROSE BARBITAL-EDTA BUFFER
Chemistry
50d
Cleared
Sep 17, 1979
NORMAL CONTROL
Chemistry
27d
Cleared
Sep 17, 1979
CPK ISOENZYME REAGENT
Chemistry
27d
Cleared
Sep 17, 1979
ENZYME STABILIZING REAGENT (ESR)
Chemistry
27d
Cleared
Sep 17, 1979
LDH ISOENZYME REAGENT
Chemistry
27d
Cleared
Aug 16, 1979
CPK ISOENZYME CONTROL
Chemistry
31d
Cleared
Aug 16, 1979
LDH ISOENZYME CONTROL
Chemistry
31d
Cleared
Dec 20, 1978
CLEARING SOLUTION #ECA01976
Chemistry
37d
Cleared
Aug 14, 1978
ECA HEME BUFFER
Chemistry
42d
Cleared
Aug 10, 1978
ECA BUFFER, PH 816
Chemistry
38d
Cleared
Aug 10, 1978
ECA PREP
Chemistry
38d
Cleared
Aug 10, 1978
ECA BUFFER PH 8.8
Chemistry
38d
Cleared
Aug 10, 1978
TRICHLORACETIC ACID 7.5%
Chemistry
38d
Cleared
Aug 10, 1978
PONCEAU S
Chemistry
38d
Cleared
Aug 10, 1978
CPK ISOENZYME REAGENT
Chemistry
38d
Cleared
Aug 10, 1978
LDH ISOENZYME REAGENT
Chemistry
38d