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Panels › Clinical Chemistry › Product code JJX · Class 1

Single (Specified) Analyte Controls (Assayed And Unassayed)

Regulation 862.1660

0510(k)s in 12 months (493 all time)
0recalls in 12 months (42 all time)
32recalls that name a 510(k)
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Top companies in JJX

Company510(k)sRecalls
Roche Diagnostics600
Siemens Healthcare Diagnostics346
Boehringer Mannheim Corp.240
Bionostics, Inc.220
Bio-Rad210
Ortho-Clinical Diagnostics133
Abbott Laboratories49
Beckman Coulter, Inc.94
Casco Standards100
Tosoh Medics, Inc.100
Decided510(k)Device and applicantCode
Apr 29, 1985K851042SUGAR-CHEX
Streck Laboratories, Inc.
JJX
Apr 10, 1985K851079BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3
Beckman Instruments, Inc.
JJX
Sep 28, 1984K843569PRECISET AMMONIA
Boehringer Mannheim Corp.
JJX
Jan 13, 1984K833898TRI-LEVEL BILIRUBIN CONTROLS
Sandare Chemical Co., Inc.
JJX
Jan 11, 1984K833097CHEM TRAK LIQUID BILIRUBIN CONTROL
Medical Analysis Systems, Inc.
JJX
Jul 19, 1983K831523BETA SCAN NORMAL CONTROL SOLUTION
Orange Medical Instruments, Inc.
JJX
Jul 18, 1983K831527SPINAL FLUID TOTAL PROTEIN CONTROL
Quantimetrix Corp.
JJX
Apr 18, 1983K830493PROTOPORPHYRIN ZN CONTROL
Kaulson Laboratories, Inc.
JJX
Apr 5, 1983K823421PHADEBAS HUMYLASE CONTROL(H)
Pharmacia, Inc.
JJX
Feb 18, 1983K830204DAC-CEL DIAGNATAL HCG STANDARDS RD49
Wellcome Diagnostics
JJX
Jan 7, 1983K823687BIO INTERFERENCE BLANKING MATERIAL
American Monitor Corp.
JJX
Jan 7, 1983K823186ESTROCEPT STABILIZED ESTROGEN RECEPTOR
Brl
JJX
Dec 28, 1982K822219HUMAN PLASMA CONTROL FOR CEA-ROCHE
Hoffmann-La Roche, Inc.
JJX
Dec 14, 1982K823353CARCINO-CEK
Biologics Intl., Inc.
JJX
Nov 5, 1982K822938PHADEBASE HUMYLASE CONTROL
Pharmacia, Inc.
JJX
Sep 30, 1982K822698GLUCOSCAN CONTROLS
Lifescan, Inc.
JJX
Jul 2, 1982K821742POSITIVE & NEGATIVE HCG URINE CONTROLS
Armkel, LLC
JJX
Jul 2, 1982K821558LEVEL II CONTROL SERUM
Irvine Scientific
JJX
May 12, 1982K820772FETAL-TEK CONTROL (IMMATURE/BORDERLINE)
Helena Laboratories
JJX
Oct 6, 1981K812690C-PEPTIDE CONTROL PACK
Mallinckrodt Critical Care
JJX
Jul 23, 1981K811912HELENA VMA-SMC CONTROL
Helena Laboratories
JJX
Jul 15, 1981K811832PRECINORM U & PRECIPATH U HUMAN SERUM
Boehringer Mannheim Corp.
JJX
May 15, 1981K811150URINE PREGNANCY TEST STANDARD/CONTR. PK
Mallinckrodt Critical Care
JJX
Dec 22, 1980K802997HDL-CHOLESTEROL CONTROL SERUM
Isolab, Inc.
JJX
Oct 10, 1980K802068ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO
Beckman Instruments, Inc.
JJX
Sep 16, 1980K801854SPINAL FLUID CONTROL(HUMAN)
Environmental Chemical Specialties
JJX
Apr 16, 1980K800708CODE QAS.105 PROLACTIN CONTROL SERA
Amersham Corp.
JJX
Jan 21, 1980K800035PENTEX LIPOPROTEIN CHOLESTEROL SOLU.
Miles Laboratories, Inc.
JJX
Jan 16, 1980K792524CK-MB (CREATINE KINASE-MB) RIA CONTROL
Mallinckrodt Critical Care
JJX
Oct 11, 1979K791957SERACON -LO DO26
Bhp Diagnostix, Inc.
JJX
Aug 10, 1979K791141BILIRUBIN CALIBRATOR CONTROL
Beckman Instruments, Inc.
JJX
Jul 17, 1979K791031ABNORMAL PROTEIN ELECTROPHORESIS CONTROL
Beckman Instruments, Inc.
JJX
Jul 17, 1979K791029NORMAL PROTEIN ELECTROPHORESIS CONTROL
Beckman Instruments, Inc.
JJX
Apr 4, 1979K790376DUPONT ACA CKMB VERIFIERS
E.I. Dupont DE Nemours & Co., Inc.
JJX
Mar 21, 1979K790129SERUM PAK, HCG CONTROL
Mallinckrodt Critical Care
JJX
Feb 15, 1979K782170SERACON-LP
Bhp Diagnostix, Inc.
JJX
Feb 8, 1979K782171SERACON-HDL
Bhp Diagnostix, Inc.
JJX
Jan 6, 1978K772285ACA LIPASE VERIFIERS
E.I. Dupont DE Nemours & Co., Inc.
JJX
Oct 28, 1977K771798ACA BILIRUBIN CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
JJX
Oct 13, 1977K771657EMIT THYROXINE CONTROL
Syva Co.
JJX
Jul 11, 1977K770795SHAVE PREP SET
Lukens Corp.
JJX
Nov 5, 1976K760885KETOTROL-E
Sigma Chemical Co.
JJX
Oct 29, 1976K760449LIPID CONTROL
Sigma Chemical Co.
JJX

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