FDA Product Code
FDA Product Code JJY — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1660
510(k) Clearances — 673 records · page 7 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K833423 | VENTREZYME EIA CONTROLS-IMMUNOASSAY | Ventrex Laboratories, Inc. | 1983-12-08 | Traditional | PDF ↗ |
| K833191 | ABNORMAL URINE CONTROL | Biosan Laboratories, Inc. | 1983-12-08 | Traditional | PDF ↗ |
| K833192 | NORMAL URINE CONTROL | Biosan Laboratories, Inc. | 1983-12-08 | Traditional | PDF ↗ |
| K831263 | ELECTROPHORESIS CONTROLS-3 IN 1 | Corning Medical & Scientific | 1983-07-07 | Traditional | PDF ↗ |
| K830179 | BIOCELL SPINAL FLUID CONTROL | Biocell Laboratories, Inc. | 1983-02-18 | Traditional | PDF ↗ |
| K823352 | IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS | American Dade | 1983-02-07 | Traditional | PDF ↗ |
| K823929 | MULTIANALYTE CONTROLS-ALL KINDS | Fisher Scientific Co., LLC | 1983-01-28 | Traditional | PDF ↗ |
| K823490 | ORTHO BI-LEVEL ASSAYED LIPID PROFILE | Ortho Diagnostic Systems, Inc. | 1983-01-05 | Traditional | PDF ↗ |
| K822850 | MONI-TRO ES CHEMISTRY CONTROL LEVEL IX | American Dade | 1982-10-27 | Traditional | PDF ↗ |
| K821982 | TITAN GEL SERUM CONTROL | Helena Laboratories | 1982-08-16 | Traditional | PDF ↗ |
| K821026 | BI-LEVEL ASSAYED TUMOR MARKER & ANTIN | Ortho Diagnostic Systems, Inc. | 1982-08-10 | Traditional | PDF ↗ |
| K822133 | IGE/THE OPHYLLINE CONTROL SERUM I,II,III | Kallestad Laboratories, Inc. | 1982-08-03 | Traditional | PDF ↗ |
| K821560 | LEVEL II LIPID CONTROL | Irvine Scientific | 1982-07-13 | Traditional | PDF ↗ |
| K821559 | LEVEL I LIPID CONTROL | Irvine Scientific | 1982-07-13 | Traditional | PDF ↗ |
| K821557 | LEVEL I CONTROL SERUM | Irvine Scientific | 1982-07-08 | Traditional | PDF ↗ |
| K821382 | CHEMISTRY CONTROL/STANDARD | Medical Analysis Systems, Inc. | 1982-05-28 | Traditional | PDF ↗ |
| K821242 | RESPONSE LIQUID LIGAND ASSAY SERUM | Beckman Instruments, Inc. | 1982-05-21 | Traditional | PDF ↗ |
| K820255 | BI-LEVEL ASSAYED URINE METAL CONTROL | Ortho Diagnostic Systems, Inc. | 1982-02-18 | Traditional | PDF ↗ |
| K813580 | Q-LINE LTC | Miles Laboratories, Inc. | 1982-01-18 | Traditional | PDF ↗ |
| K813294 | ORTHO CO2 DILUENT LEVEL II | Ortho Diagnostic Systems, Inc. | 1981-12-17 | Traditional | PDF ↗ |
| K813322 | ORTHO* UNASSAYED CONTROL SERUM LEVEL III | Ortho Diagnostic Systems, Inc. | 1981-12-17 | Traditional | PDF ↗ |
| K813295 | ORTHO CO2 DILUENT LEVEL III | Ortho Diagnostic Systems, Inc. | 1981-12-17 | Traditional | PDF ↗ |
| K813321 | ORTHO* UNASSAYED CONTROL SERUM LEVEL I | Ortho Diagnostic Systems, Inc. | 1981-12-17 | Traditional | PDF ↗ |
| K813293 | ORTHO CO2 DILUENT LEVEL I | Ortho Diagnostic Systems, Inc. | 1981-12-17 | Traditional | PDF ↗ |
| K813167 | ORTHO UNASSAYED CONTROL SERUM LEVEL II | Ortho Diagnostic Systems, Inc. | 1981-11-24 | Traditional | PDF ↗ |
| K812556 | DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C | American Dade | 1981-11-02 | Traditional | PDF ↗ |
| K812650 | BECKMAN ICS NORMAL CONTROL SERA | Beckman Instruments, Inc. | 1981-10-19 | Traditional | PDF ↗ |
| K812635 | ANEMIA CONTROL | Environmental Chemical Specialties | 1981-10-02 | Traditional | PDF ↗ |
| K812583 | BOVINE CHEMISTRY CONTROL I.X. & II.X. | American Dade | 1981-09-24 | Traditional | PDF ↗ |
| K811695 | HELENA FETAL-TEK 200 MARKER | Helena Laboratories | 1981-07-01 | Traditional | PDF ↗ |
| K811467 | DOXEPIN/DESMETHLDOXEPIN/LITHIUM | Ortho Diagnostic Systems, Inc. | 1981-06-12 | Traditional | PDF ↗ |
| K811465 | IMIPRAMINE/DISIPRAMINE/LITHIUM | Ortho Diagnostic Systems, Inc. | 1981-06-12 | Traditional | PDF ↗ |
| K811466 | AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM | Ortho Diagnostic Systems, Inc. | 1981-06-12 | Traditional | PDF ↗ |
| K811182 | MULTIANALYTE CONTROLS, ALL KINDS | Fisher Scientific Co., LLC | 1981-05-15 | Traditional | PDF ↗ |
| K811100 | GELMAN ELECTROPHORESIS CONTROL | Gelman Sciences, Inc. | 1981-05-01 | Traditional | PDF ↗ |
| K810952 | CORNING VITAMIN B12 FOLATE DEFIC. CONTR. | Corning Medical & Scientific | 1981-04-17 | Traditional | PDF ↗ |
| K810906 | TRI-LEVEL NDI CONTROL | Nuclear Diagnostics, Inc. | 1981-04-14 | Traditional | PDF ↗ |
| K803098 | TRI-LEVEL RADIOASSAY CONTROL SERA | American Diagnostic Corp. | 1981-01-09 | Traditional | PDF ↗ |
| K802962 | CHEM-ASSAY STANDARD-CONTROLS | National Bio-Technical Laboratories | 1980-12-22 | Traditional | PDF ↗ |
| K802109 | KEMTROL SERUM CONTROL ABNORMAL | Helena Laboratories | 1980-10-10 | Traditional | PDF ↗ |
| K802108 | KEMTROL SERUM CONTROL-NORMAL | Helena Laboratories | 1980-10-10 | Traditional | PDF ↗ |
| K801539 | ASSURE LEVEL II PROD. #30172 | Warner-Lambert Co. | 1980-09-09 | Traditional | PDF ↗ |
| K801538 | ASSURE LEVEL I PROD. #30171 | Warner-Lambert Co. | 1980-09-09 | Traditional | PDF ↗ |
| K801335 | UNASSAYED CHEMISTRY SERUM CONTROL(BOVINE | Warner-Lambert Co. | 1980-07-08 | Traditional | PDF ↗ |
| K800813 | DIAGNOSTIC PRODUCTS CORP. RIA CONTROL | Diagnostic Products Corp. | 1980-04-24 | Traditional | PDF ↗ |
| K800559 | SERTROL PRODUCT # ACS ST 101 | Analytical Control Systems, Inc. | 1980-03-25 | Traditional | PDF ↗ |
| K800558 | LIPID CONTROL PRODUCT # ACS LC 101 | Analytical Control Systems, Inc. | 1980-03-25 | Traditional | PDF ↗ |
| K800370 | CK/LD ISOENZYME CONTROL PROD. #ACS CT101 | Analytical Control Systems, Inc. | 1980-03-12 | Traditional | PDF ↗ |
| K792375 | ELEVATED LIPID CONTROL | Environmental Chemical Specialties | 1979-12-06 | Traditional | PDF ↗ |
| K792024 | LIPOTROL | Helena Laboratories | 1979-10-30 | Traditional | PDF ↗ |
| K792025 | LYOPHILIZED HDL CHOLESTEROL CONTROLS | Helena Laboratories | 1979-10-30 | Traditional | PDF ↗ |
| K791958 | SERACON - EL DO27 | Bhp Diagnostix, Inc. | 1979-10-17 | Traditional | PDF ↗ |
| K791825 | LY-PRO-TROL #ACS-LP101 | Analytical Control Systems, Inc. | 1979-10-01 | Traditional | PDF ↗ |
| K791696 | CONTRO II | Hi Chem, Inc. | 1979-09-24 | Traditional | PDF ↗ |
| K791695 | CONTRO I | Hi Chem, Inc. | 1979-09-24 | Traditional | PDF ↗ |
| K791654 | NORMAL CONTROL | Electrophoresis Corp. of America | 1979-09-17 | Traditional | PDF ↗ |
| K791313 | ARS, CHEMISTRY | Mid Tech, Inc. | 1979-08-16 | Traditional | PDF ↗ |
| K791119 | MACOMB NORMAL CONTROL SERUM | Macomb Chemical Co. | 1979-07-30 | Traditional | PDF ↗ |
| K790840 | THYROID CONTROL SERA CODE QAS.101 | Amersham Corp. | 1979-06-28 | Traditional | PDF ↗ |
| K790371 | MACOMB LIPID CONTROL | Macomb Chemical Co. | 1979-04-04 | Traditional | PDF ↗ |
| K790264 | DATA-TOPE TRI-RAC RADIOASSAY CONTROL | Dade, Baxter Travenol Diagnostics, Inc. | 1979-03-21 | Traditional | PDF ↗ |
| K790330 | CALBIOCHEM-BEHRING LASER IMMUNOGLOBULIN | Calbiochem-Behring Corp. | 1979-03-15 | Traditional | PDF ↗ |
| K782038 | SERACON-C | Bhp Diagnostix, Inc. | 1979-02-08 | Traditional | PDF ↗ |
| K781893 | CONTROL, PROTEIN ELECTROPHORESIS | Sigma Chemical Co. | 1978-12-20 | Traditional | PDF ↗ |
| K781593 | RIA CONTROLS | Dade, Baxter Travenol Diagnostics, Inc. | 1978-10-17 | Traditional | PDF ↗ |
| K780552 | COMP. CLIN. CHEM. CONTROL SERUM-DECISION | Beckman Instruments, Inc. | 1978-05-19 | Traditional | PDF ↗ |
| K780351 | NORMAL UNASSAYED CONTROL SERA | Macomb Chemical Co. | 1978-04-24 | Traditional | PDF ↗ |
| K780096 | LDH ISOENZYME CONTROL SERUM | Worthington Biochemical Corp. | 1978-03-03 | Traditional | PDF ↗ |
| K771437 | SERONORM LIPID | Nyegaard & Co. A/S | 1977-09-02 | Traditional | PDF ↗ |
| K770380 | CHEMISTRY CONTROL-LOW & HIGH TQC TM | Technicon Instruments Corp. | 1977-04-15 | Traditional | PDF ↗ |
| K770312 | CHEMISTRY CONTROL, ABNORMAL | Icn Pharmaceuticals, Inc. | 1977-04-05 | Traditional | PDF ↗ |
| K770310 | CHEMISTRY CONTROL, NORMAL | Icn Pharmaceuticals, Inc. | 1977-04-05 | Traditional | PDF ↗ |
| K760818 | TRIS BICARBONATE DILUENT | Hyland Therapeutic Div., Travenol Laboratories | 1976-11-05 | Traditional | PDF ↗ |
Product code JJY · Class I · Clinical Chemistry. Data: openFDA.