Streck Laboratories, Inc. - FDA 510(k) Cleared Devices
70
Total
70
Cleared
0
Denied
50 devices
Cleared
Feb 20, 1991
RETIC-CHEX
Hematology
72d
Cleared
May 30, 1990
PARA 12 PLUS
Hematology
34d
Cleared
Mar 09, 1990
RET-CHECK
Hematology
36d
Cleared
Nov 09, 1989
PARA TECH FOR TECHNICON H-1
Hematology
16d
Cleared
Mar 23, 1989
NE-CHECK
Hematology
36d
Cleared
Jul 01, 1988
PAT PLATELET AGGREGATION TEST
Hematology
63d
Cleared
Oct 10, 1985
PARA CHECK (AKA EIGHT CHECK-C)
Hematology
87d
Cleared
Jul 05, 1985
SICKLE-CHEX
Hematology
51d
Cleared
Oct 23, 1984
RETIC-CHEX
Hematology
77d
Cleared
Jul 27, 1984
PARA-TEK
Hematology
102d
Cleared
Jun 26, 1984
PARA 4
Hematology
39d
Cleared
Feb 21, 1984
CAL-CHEX, A HEMATOLOGY CALIBRATOR
Hematology
47d
Cleared
Jun 08, 1983
PARA LASAR
Hematology
65d
Cleared
Dec 28, 1982
PARA 12
Hematology
34d
Cleared
Sep 24, 1981
CELL-CHEX RBC
Hematology
97d
Cleared
Dec 11, 1980
PLATELET COUNTING KIT
Hematology
49d
Cleared
Apr 04, 1980
HEMATO-CHEX
Hematology
44d
Cleared
Dec 31, 1979
PLATELET-CHEX FOR BLOOD CENTERS
Hematology
28d
Cleared
Aug 03, 1979
PLATELET-CHEX PLUS
Hematology
32d
Cleared
Aug 03, 1979
PARA-7
Hematology
32d
Cleared
Aug 03, 1979
PARA-8
Hematology
32d
Cleared
Aug 14, 1978
PC-CALIBRATOR
Hematology
39d
Cleared
Mar 27, 1978
CELL-CHEX
Hematology
60d
Cleared
Nov 30, 1977
PLATELET KIT
Hematology
23d
Cleared
Feb 16, 1977
PLATELET-CHEX-HUMAN
Hematology
41d