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
409–432 of 493
Cleared Apr 29, 1985
SUGAR-CHEX
K851042
Streck Laboratories, Inc.
Chemistry · 46d
Cleared Apr 29, 1985
SUGAR-CHEX II
K851043
Streck Laboratories, Inc.
Chemistry · 46d
Cleared Apr 10, 1985
BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3
K851079
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Sep 28, 1984
PRECISET AMMONIA
K843569
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Jan 13, 1984
TRI-LEVEL BILIRUBIN CONTROLS
K833898
Sandare Chemical Co., Inc.
Chemistry · 60d
Cleared Jan 11, 1984
CHEM TRAK LIQUID BILIRUBIN CONTROL
K833097
Medical Analysis Systems, Inc.
Chemistry · 121d
Cleared Jul 18, 1983
SPINAL FLUID TOTAL PROTEIN CONTROL
K831527
Quantimetrix Corp.
Chemistry · 67d
Cleared Apr 05, 1983
PHADEBAS HUMYLASE CONTROL(H)
K823421
Pharmacia, Inc.
Chemistry · 138d
Cleared Feb 18, 1983
DAC-CEL DIAGNATAL HCG STANDARDS RD49
K830204
Wellcome Diagnostics
Chemistry · 29d
Cleared Jan 07, 1983
BIO INTERFERENCE BLANKING MATERIAL
K823687
American Monitor Corp.
Chemistry · 31d
Cleared Dec 28, 1982
HUMAN PLASMA CONTROL FOR CEA-ROCHE
K822219
Hoffmann-La Roche, Inc.
Immunology · 155d
Cleared Nov 05, 1982
PHADEBASE HUMYLASE CONTROL
K822938
Pharmacia, Inc.
Chemistry · 32d
Cleared Sep 30, 1982
GLUCOSCAN CONTROLS
K822698
Lifescan, Inc.
Chemistry · 23d
Cleared Jul 02, 1982
POSITIVE & NEGATIVE HCG URINE CONTROLS
K821742
Armkel, LLC
Chemistry · 18d
Cleared May 12, 1982
FETAL-TEK CONTROL (IMMATURE/BORDERLINE)
K820772
Helena Laboratories
Chemistry · 50d
Cleared Oct 06, 1981
C-PEPTIDE CONTROL PACK
K812690
Mallinckrodt Critical Care
Chemistry · 14d
Cleared Jul 23, 1981
HELENA VMA-SMC CONTROL
K811912
Helena Laboratories
Chemistry · 22d
Cleared Jul 15, 1981
PRECINORM U & PRECIPATH U HUMAN SERUM
K811832
Boehringer Mannheim Corp.
Chemistry · 16d
Cleared May 15, 1981
URINE PREGNANCY TEST STANDARD/CONTR. PK
K811150
Mallinckrodt Critical Care
Chemistry · 18d
Cleared Dec 22, 1980
HDL-CHOLESTEROL CONTROL SERUM
K802997
Isolab, Inc.
Chemistry · 27d
Cleared Oct 10, 1980
ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO
K802068
Beckman Instruments, Inc.
Chemistry · 44d
Cleared Apr 16, 1980
CODE QAS.105 PROLACTIN CONTROL SERA
K800708
Amersham Corp.
Chemistry · 16d
Cleared Jan 21, 1980
PENTEX LIPOPROTEIN CHOLESTEROL SOLU.
K800035
Miles Laboratories, Inc.
Chemistry · 14d
Cleared Jan 16, 1980
CK-MB (CREATINE KINASE-MB) RIA CONTROL
K792524
Mallinckrodt Critical Care
Chemistry · 41d