Medical Device Manufacturer · US , Grover Beach , CA

Clinical Controls, Inc.

17 submissions · 17 cleared · Since 1994
17
Total
17
Cleared
0
Denied

Clinical Controls, Inc. — FDA 510(k) Submissions

Clinical Controls, Inc. has submitted 17 FDA 510(k) premarket notifications since 1994, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Single (specified) Analyte Controls (assayed And Unassayed), Multi-analyte Controls, All Kinds (assayed), Enzyme Controls (assayed And Unassayed), Plasma, Fibrinogen Control, System, Test, Beta-2-microglobulin Immunological . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6
K964278 · JJX Single (specified)... · Chemistry
Nov 1996 25d
LIQUISPEX URINE (MICRO)ALBUMIN CONTROL
K962432 · JJX Single (specified)... · Chemistry
Jul 1996 11d
AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3
K955690 · JJY Multi-analyte Controls,... · Chemistry
Apr 1996 132d
SERUM VOLATILES CONTROL LEVEL 1 & 2
K955691 · JJY Multi-analyte Controls,... · Chemistry
Apr 1996 132d
FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3
K946265 · GIL Plasma, Fibrinogen Control · Hematology
Aug 1995 244d
PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2
K935598 · GIL Plasma, Fibrinogen Control · Hematology
May 1995 529d
LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2
K946048 · JZG System, Test,... · Immunology
Feb 1995 60d
LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2
K946049 · JJY Multi-analyte Controls,... · Chemistry
Feb 1995 60d
LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2
K946050 · DCK C-reactive Protein,... · Immunology
Feb 1995 60d
FERRITIN CONTROL - LEVEL 1, 2, 3
K946266 · DGD Igg, Ferritin, Antigen,... · Immunology
Feb 1995 49d
LIQUISPEX(TM) URINE ETHANOL CONTROL
K946144 · JJX Single (specified)... · Toxicology
Feb 1995 54d
CHEMSPEX(TM) AMMONIA CONTROL
K946143 · JJX Single (specified)... · Chemistry
Feb 1995 49d
CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL
K946145 · JJT Enzyme Controls (assayed... · Chemistry
Jan 1995 39d
CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION
K946146 · JJT Enzyme Controls (assayed... · Chemistry
Jan 1995 39d
CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3,
K944923 · JJT Enzyme Controls (assayed... · Chemistry
Nov 1994 29d
HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3
K935599 · JJY Multi-analyte Controls,... · Chemistry
Oct 1994 346d
LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2
K934741 · GIL Plasma, Fibrinogen Control · Hematology
Sep 1994 342d
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