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
385–408 of 493
Cleared Jul 27, 1990
AMERSHAM TSH CONTROL SERA
K902760
Amersham Corp.
Chemistry · 32d
Cleared Jul 16, 1990
CHEM-CHEX BILIRUBIN
K902867
Streck Laboratories, Inc.
Chemistry · 17d
Cleared May 30, 1990
ROTAG CONTROLS
K900719
Roche Diagnostic Systems, Inc.
Chemistry · 105d
Cleared Feb 26, 1990
POSITIVE AND NEGATIVE HCG SERUM CONTROLS
K896875
Armkel, LLC
Chemistry · 80d
Cleared Oct 25, 1989
GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104
K895528
Helena Laboratories
Chemistry · 49d
Cleared Oct 23, 1989
MICRO-PLATE READER, MDX-1
K894400
Medix Biotech, Inc.
Chemistry · 96d
Cleared Sep 28, 1989
SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)
K894804
Lifescan, Inc.
Chemistry · 62d
Cleared Sep 05, 1989
RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL
K894329
Amersham Corp.
Chemistry · 53d
Cleared Aug 31, 1989
POSITIVE AND NEGATIVE HCG URINE CONTROLS
K894181
Armkel, LLC
Chemistry · 76d
Cleared Aug 01, 1989
LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3
K891475
Bio-Rad
Chemistry · 138d
Cleared Jun 23, 1989
DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET
K893140
Casco Standards
Chemistry · 59d
Cleared May 22, 1989
DRI-DYE CHECK STRIPS (TM)-405
K892656
Awareness Technology, Inc.
Chemistry · 39d
Cleared Oct 03, 1988
QTEST PREGNANCY TEST CONTROL
K883741
Quidel Corp.
Chemistry · 32d
Cleared Sep 22, 1988
QUIDEL PREGNANCY TEST CONTROL
K883316
Quidel Corp.
Chemistry · 48d
Cleared Feb 24, 1988
AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665
K880039
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Oct 20, 1987
BILE ACIDS CONTROLS
K873342
Sigma Diagnostics, Inc.
Chemistry · 62d
Cleared Sep 21, 1987
TRI-LEVEL LIGAND CONTROL
K873450
Ciba Corning Diagnostics Corp.
Immunology · 25d
Cleared Sep 16, 1987
REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL
K873105
Streck Laboratories, Inc.
Chemistry · 40d
Cleared Mar 12, 1987
TOTAL/IGE THEOPHYLLINE CONTROL SERA
K870151
3M Company
Immunology · 58d
Cleared Sep 15, 1986
TESTPACK ACUTE HCG SERUM CONTROLS
K863126
Abbott Laboratories
Chemistry · 31d
Cleared Apr 24, 1986
EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST
K861221
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Feb 19, 1986
ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040
K860453
Sigma Diagnostics, Inc.
Chemistry · 14d
Cleared Jan 17, 1986
ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL
K855225
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Sep 16, 1985
DIASCAN CONTROL
K853553
Home Diagnostics, Inc.
Chemistry · 21d