JJX · Class I · 21 CFR 862.1660

FDA Product Code JJX: Single (specified) Analyte Controls (assayed And Unassayed)

Leading manufacturers include Roche Diagnostics, Siemens Healthcare Diagnostics, Inc. and Boehringer Mannheim Corp..

493
Total
493
Cleared
62d
Avg days
1976
Since
493 devices
241–264 of 493
Cleared Nov 24, 1998
ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05
K984072
Bio-Rad
Chemistry · 8d
Cleared Nov 18, 1998
CARDIAC MARKER CONTROL MODULE, MODEL CCCM
K983971
Diagnostic Products Corp.
Chemistry · 9d
Cleared Nov 12, 1998
ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05
K983578
Bio-Rad
Chemistry · 30d
Cleared Aug 06, 1998
B2-MICROGLOBULIN CONTROL SET SERUM
K982471
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Aug 05, 1998
DADE TRU-LIQUID CARDIAC CONTROL
K982591
Dade Behring, Inc.
Chemistry · 12d
Cleared Jul 06, 1998
VIGIL HEMOGLOBIN (HBALC) CONTROLS
K982022
Beckman Coulter, Inc.
Hematology · 27d
Cleared Jun 12, 1998
ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219
K981864
Beckman Coulter, Inc.
Chemistry · 16d
Cleared Jun 08, 1998
DADE TRU-LIQUID CARDIAC CONTROL
K981622
Dade Behring, Inc.
Chemistry · 32d
Cleared Apr 24, 1998
ELECSYS CALCHECK FERRITIN
K981281
Roche Diagnostics GmbH
Chemistry · 16d
Cleared Apr 23, 1998
ELECSYS CALCHECK CA 125II
K981278
Roche Diagnostics GmbH
Chemistry · 15d
Cleared Feb 10, 1998
ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL
K974811
Boston Biomedica, Inc.
Microbiology · 49d
Cleared Jan 13, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
K974644
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 32d
Cleared Jan 06, 1998
REP CHOLESTEROL PROFILE CONTROL-II
K974609
Helena Laboratories
Chemistry · 27d
Cleared Dec 16, 1997
PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH
K973676
Sorrento Biochemical, Inc.
Chemistry · 81d
Cleared Dec 15, 1997
DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH
K973677
Sorrento Biochemical, Inc.
Chemistry · 80d
Cleared Dec 15, 1997
ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH
K973678
Sorrento Biochemical, Inc.
Chemistry · 80d
Cleared Dec 08, 1997
ELECSYS CALCHECK VITAMIN B12
K974383
Boehringer Mannheim Corp.
Chemistry · 17d
Cleared Nov 26, 1997
SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)
K974108
Quidel Corp.
Chemistry · 26d
Cleared Oct 27, 1997
OPUS HLH CONTROLS
K973832
Behring Diagnostics, Inc.
Toxicology · 20d
Cleared Oct 06, 1997
MYOGLOBIN CONTROL SET
K973358
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Sep 29, 1997
PROSTATE SPECIFIC ANTIGEN CONTROL
K973099
Dade Chemistry Systems, Inc.
Immunology · 41d
Cleared Sep 12, 1997
WAKO NEFA LINEARITY SET
K973072
Wako Chemicals USA, Inc.
Toxicology · 25d
Cleared Aug 06, 1997
ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P
K972721
Roche Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Jul 28, 1997
CARDIAC STATUS CONTROLS/TROPONIN I
K972687
Spectral Diagnostics, Inc.
Chemistry · 11d