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
313–336 of 493
Cleared Apr 03, 1995
IMMULITE(R) TBG
K950072
Diagnostic Products Corp.
Chemistry · 84d
Cleared Mar 30, 1995
REP CHOLESTEROL PROFILE CONTROL
K950590
Helena Laboratories
Chemistry · 49d
Cleared Mar 20, 1995
CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL
K950589
Creative Laboratory Products, Inc.
Chemistry · 39d
Cleared Feb 08, 1995
LIQUISPEX(TM) URINE ETHANOL CONTROL
K946144
Clinical Controls, Inc.
Toxicology · 54d
Cleared Feb 03, 1995
CHEMSPEX(TM) AMMONIA CONTROL
K946143
Clinical Controls, Inc.
Chemistry · 49d
Cleared Jan 17, 1995
SAS QUANT HCG SERUM
K944785
Sa Scientific, Inc.
Chemistry · 111d
Cleared Jan 17, 1995
DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET
K945718
Casco Standards
Chemistry · 57d
Cleared Nov 30, 1994
DOCUMENT R AMMONIA/ETHANOL CONTROL
K944361
Casco Standards
Chemistry · 84d
Cleared Nov 22, 1994
QUANTITATE URIC ACID VERIFIER SET
K944453
Beckman Instruments, Inc.
Chemistry · 71d
Cleared Nov 17, 1994
SAS QUANT HCG URINE
K944891
Sa Scientific, Inc.
Chemistry · 44d
Cleared Nov 15, 1994
DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET
K944338
Casco Standards
Chemistry · 70d
Cleared Sep 09, 1994
TNT TROPONIN T
K942632
Streck Laboratories, Inc.
Immunology · 98d
Cleared Aug 26, 1994
CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET
K942284
Creative Laboratory Products, Inc.
Chemistry · 107d
Cleared Aug 02, 1994
HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH
K941433
Hichem Diagnostics
Chemistry · 131d
Cleared Jun 21, 1994
AXSYM LUTEINIZING HORMONE (LH)
K935611
Abbott Laboratories
Chemistry · 211d
Cleared Jun 13, 1994
GLUCOMETER ELITE LOW CONTROL
K940577
Heraeus Kulzer, Inc.
Chemistry · 125d
Cleared Jun 03, 1994
ASSURE URINE HCG CONTROL
K941130
Quantimetrix Corp.
Chemistry · 86d
Cleared Apr 20, 1994
ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
K940272
Analytical Control Systems, Inc.
Chemistry · 98d
Cleared Apr 05, 1994
DOCUMENT(R) ZERO
K940568
Casco Standards
Chemistry · 56d
Cleared Dec 29, 1993
CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET
K934922
Unipath , Ltd.
Chemistry · 77d
Cleared Dec 29, 1993
CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET
K934923
Unipath , Ltd.
Chemistry · 77d
Cleared Nov 26, 1993
SPQ MALB CONTROL LEVEL II
K934521
Incstar Corp.
Chemistry · 70d
Cleared Oct 28, 1993
LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2
K932660
More Diagnostics
Chemistry · 148d
Cleared Sep 24, 1993
SAS(TM) HCG URINE CONTROLS, VARIOUS SIZES
K933744
Sa Scientific, Inc.
Chemistry · 57d