Panels › Clinical Chemistry › Product code JJY · Class 1
Multi-Analyte Controls, All Kinds (Assayed)
Regulation 862.1660
0510(k)s in 12 months (673 all time)
2recalls in 12 months (95 all time)
73recalls that name a 510(k)
Top companies in JJY
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio-Rad | 61 | 0 |
| Randox Laboratories Limited | 15 | 31 |
| Medical Analysis Systems, Inc. | 31 | 0 |
| Bio-Rad Laboratories | 26 | 1 |
| Roche Diagnostics | 22 | 4 |
| Cliniqa Corporation | 22 | 0 |
| Aalto Scientific, Ltd. | 19 | 0 |
| Maine Standards Co. | 19 | 0 |
| Boehringer Mannheim Corp. | 17 | 0 |
| Casco Standards | 15 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 8, 1983 | K833423 | VENTREZYME EIA CONTROLS-IMMUNOASSAY Ventrex Laboratories, Inc. | JJY |
| Dec 8, 1983 | K833192 | NORMAL URINE CONTROL Biosan Laboratories, Inc. | JJY |
| Dec 8, 1983 | K833191 | ABNORMAL URINE CONTROL Biosan Laboratories, Inc. | JJY |
| Jul 7, 1983 | K831263 | ELECTROPHORESIS CONTROLS-3 IN 1 Corning Medical & Scientific | JJY |
| Feb 18, 1983 | K830179 | BIOCELL SPINAL FLUID CONTROL Biocell Laboratories, Inc. | JJY |
| Feb 7, 1983 | K823352 | IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS American Dade | JJY |
| Jan 28, 1983 | K823929 | MULTIANALYTE CONTROLS-ALL KINDS Fisher Scientific Co., LLC | JJY |
| Jan 5, 1983 | K823490 | ORTHO BI-LEVEL ASSAYED LIPID PROFILE Ortho Diagnostic Systems, Inc. | JJY |
| Oct 27, 1982 | K822850 | MONI-TRO ES CHEMISTRY CONTROL LEVEL IX American Dade | JJY |
| Aug 16, 1982 | K821982 | TITAN GEL SERUM CONTROL Helena Laboratories | JJY |
| Aug 10, 1982 | K821026 | BI-LEVEL ASSAYED TUMOR MARKER & ANTIN Ortho Diagnostic Systems, Inc. | JJY |
| Aug 3, 1982 | K822133 | IGE/THE OPHYLLINE CONTROL SERUM I,II,III Kallestad Laboratories, Inc. | JJY |
| Jul 13, 1982 | K821560 | LEVEL II LIPID CONTROL Irvine Scientific | JJY |
| Jul 13, 1982 | K821559 | LEVEL I LIPID CONTROL Irvine Scientific | JJY |
| Jul 8, 1982 | K821557 | LEVEL I CONTROL SERUM Irvine Scientific | JJY |
| May 28, 1982 | K821382 | CHEMISTRY CONTROL/STANDARD Medical Analysis Systems, Inc. | JJY |
| May 21, 1982 | K821242 | RESPONSE LIQUID LIGAND ASSAY SERUM Beckman Instruments, Inc. | JJY |
| Feb 18, 1982 | K820255 | BI-LEVEL ASSAYED URINE METAL CONTROL Ortho Diagnostic Systems, Inc. | JJY |
| Jan 18, 1982 | K813580 | Q-LINE LTC Miles Laboratories, Inc. | JJY |
| Dec 17, 1981 | K813322 | ORTHO* UNASSAYED CONTROL SERUM LEVEL III Ortho Diagnostic Systems, Inc. | JJY |
| Dec 17, 1981 | K813321 | ORTHO* UNASSAYED CONTROL SERUM LEVEL I Ortho Diagnostic Systems, Inc. | JJY |
| Dec 17, 1981 | K813295 | ORTHO CO2 DILUENT LEVEL III Ortho Diagnostic Systems, Inc. | JJY |
| Dec 17, 1981 | K813294 | ORTHO CO2 DILUENT LEVEL II Ortho Diagnostic Systems, Inc. | JJY |
| Dec 17, 1981 | K813293 | ORTHO CO2 DILUENT LEVEL I Ortho Diagnostic Systems, Inc. | JJY |
| Nov 24, 1981 | K813167 | ORTHO UNASSAYED CONTROL SERUM LEVEL II Ortho Diagnostic Systems, Inc. | JJY |
| Nov 2, 1981 | K812556 | DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C American Dade | JJY |
| Oct 19, 1981 | K812650 | BECKMAN ICS NORMAL CONTROL SERA Beckman Instruments, Inc. | JJY |
| Oct 2, 1981 | K812635 | ANEMIA CONTROL Environmental Chemical Specialties | JJY |
| Sep 24, 1981 | K812583 | BOVINE CHEMISTRY CONTROL I.X. & II.X. American Dade | JJY |
| Jul 1, 1981 | K811695 | HELENA FETAL-TEK 200 MARKER Helena Laboratories | JJY |
| Jun 12, 1981 | K811467 | DOXEPIN/DESMETHLDOXEPIN/LITHIUM Ortho Diagnostic Systems, Inc. | JJY |
| Jun 12, 1981 | K811466 | AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM Ortho Diagnostic Systems, Inc. | JJY |
| Jun 12, 1981 | K811465 | IMIPRAMINE/DISIPRAMINE/LITHIUM Ortho Diagnostic Systems, Inc. | JJY |
| May 15, 1981 | K811182 | MULTIANALYTE CONTROLS, ALL KINDS Fisher Scientific Co., LLC | JJY |
| May 1, 1981 | K811100 | GELMAN ELECTROPHORESIS CONTROL Gelman Sciences, Inc. | JJY |
| Apr 17, 1981 | K810952 | CORNING VITAMIN B12 FOLATE DEFIC. CONTR. Corning Medical & Scientific | JJY |
| Apr 14, 1981 | K810906 | TRI-LEVEL NDI CONTROL Nuclear Diagnostics, Inc. | JJY |
| Jan 9, 1981 | K803098 | TRI-LEVEL RADIOASSAY CONTROL SERA American Diagnostic Corp. | JJY |
| Dec 22, 1980 | K802962 | CHEM-ASSAY STANDARD-CONTROLS National Bio-Technical Laboratories | JJY |
| Oct 10, 1980 | K802109 | KEMTROL SERUM CONTROL ABNORMAL Helena Laboratories | JJY |
| Oct 10, 1980 | K802108 | KEMTROL SERUM CONTROL-NORMAL Helena Laboratories | JJY |
| Sep 9, 1980 | K801539 | ASSURE LEVEL II PROD. #30172 Warner-Lambert Co. | JJY |
| Sep 9, 1980 | K801538 | ASSURE LEVEL I PROD. #30171 Warner-Lambert Co. | JJY |
| Jul 8, 1980 | K801335 | UNASSAYED CHEMISTRY SERUM CONTROL(BOVINE Warner-Lambert Co. | JJY |
| Apr 24, 1980 | K800813 | DIAGNOSTIC PRODUCTS CORP. RIA CONTROL Diagnostic Products Corp. | JJY |
| Mar 25, 1980 | K800559 | SERTROL PRODUCT # ACS ST 101 Analytical Control Systems, Inc. | JJY |
| Mar 25, 1980 | K800558 | LIPID CONTROL PRODUCT # ACS LC 101 Analytical Control Systems, Inc. | JJY |
| Mar 12, 1980 | K800370 | CK/LD ISOENZYME CONTROL PROD. #ACS CT101 Analytical Control Systems, Inc. | JJY |
| Dec 6, 1979 | K792375 | ELEVATED LIPID CONTROL Environmental Chemical Specialties | JJY |
| Oct 30, 1979 | K792025 | LYOPHILIZED HDL CHOLESTEROL CONTROLS Helena Laboratories | JJY |
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