Medical Device Manufacturer · US , Mchenry , IL

Streck Laboratories, Inc.

70 submissions · 70 cleared · Since 1977
70
Total
70
Cleared
0
Denied

Streck Laboratories, Inc. — FDA 510(k) Submissions

Streck Laboratories, Inc. has submitted 70 FDA 510(k) premarket notifications since 1977, of which 70 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Mixture, Hematology Quality Control, Single (specified) Analyte Controls (assayed And Unassayed), Multi-analyte Controls, All Kinds (assayed), Mixture, Control, White-cell And Red-cell Indices, Control, Cell Counter, Normal And Abnormal . Use the specialty filter in the sidebar to narrow results.

70 devices
1–25 of 70
RETIC-CHEX FOR CELL-DYN
K042587 · JPK Mixture, Hematology... · Hematology
Oct 2004 27d
CYTO-CHEX BCT
K040107 · JKA Tubes, Vials, Systems,... · Hematology
Jul 2004 189d
A1C-CELLULAR
K040025 · JJX Single (specified)... · Chemistry
Mar 2004 55d
SICKLE-CHEX SOLUBILITY KIT
K023656 · GHM Test, Sickle Cell · Hematology
Dec 2002 61d
MODIFICATION TO PARA 5X
K021922 · JPK Mixture, Hematology... · Hematology
Jun 2002 14d
CAL-CHEX CD PLUS
K020469 · KRX Calibrator For Cell Indices · Hematology
Apr 2002 51d
SICKLE-CHEX
K013316 · GHM Test, Sickle Cell · Hematology
Nov 2001 33d
PARA 5X
K011410 · JPK Mixture, Hematology... · Hematology
Jun 2001 49d
SUGAR CHEX ONE
K001443 · JJX Single (specified)... · Chemistry
Jun 2000 52d
PARA 12 PLUS RETICS
K000945 · GLQ Mixture, Control,... · Hematology
Apr 2000 26d
RETIC CHEX LINEARITY
K000115 · JPK Mixture, Hematology... · Hematology
Mar 2000 73d
CELL-CHEX
K000076 · GJR Control, Red-cell · Hematology
Mar 2000 53d
XE CHECK
K994388 · GLQ Mixture, Control,... · Hematology
Jan 2000 17d
PARA TECH PLUS RETICS
K993825 · JCN Control, Cell Counter,... · Hematology
Nov 1999 18d
CD-CHEX CD 34
K993126 · GGL Control, White-cell · Hematology
Nov 1999 67d
STAK-CHEX PLUS RETICS
K992887 · GLQ Mixture, Control,... · Hematology
Nov 1999 87d
CHEM-CHEX STAT (NEW)
K982290 · JJY Multi-analyte Controls,... · Chemistry
Jul 1998 23d
CD-CHEX + RBC
K960894 · GGL Control, White-cell · Hematology
May 1996 80d
CHEM-CHEX STAT
K961195 · JJY Multi-analyte Controls,... · Chemistry
May 1996 49d
CALIBRATION VERIFICATION ASSESSMENT (CVA)
K960557 · JPK Mixture, Hematology... · Hematology
Apr 1996 54d
SF-CHECK
K952245 · JPK Mixture, Hematology... · Hematology
Sep 1995 112d
SCS-1000 (SYSMEX CALIBRATOR SYSTEM)
K943268 · KSA Calibrator For Red-cell... · Hematology
Dec 1994 161d
TNT TROPONIN T
K942632 · JJX Single (specified)... · Immunology
Sep 1994 98d
CD-CHEX CD4 LOW
K931825 · GGL Control, White-cell · Hematology
Jun 1994 426d
PARA 5 DIFF
K935196 · JPK Mixture, Hematology... · Hematology
Apr 1994 161d
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