FDA Product Code
FDA Product Code CHH — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1175
510(k) Clearances — 230 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K895158 | VISION WHOLE BLOOD HDL CHOLESTEROL | Abbott Laboratories | 1989-10-02 | Traditional | PDF ↗ |
| K893916 | EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410 | Em Diagnostic Systems, Inc. | 1989-08-28 | Traditional | PDF ↗ |
| K893479 | CHOLESTEROL REAGENT SET | American Monitor Corp. | 1989-06-19 | Traditional | PDF ↗ |
| K891922 | AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325 | American Research Products Co. | 1989-06-16 | Traditional | PDF ↗ |
| K892238 | CLA 200 CHEMPRO(R) LIPID ANALYZER | Johnson & Johnson Professionals, Inc. | 1989-06-07 | Traditional | PDF ↗ |
| K890334 | TOTAL CHOLESTEROL REAGENT | Alpkem Corp. | 1989-05-03 | Traditional | PDF ↗ |
| K890267 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA | Photec Diagnostics, Inc. | 1989-04-26 | Traditional | PDF ↗ |
| K890027 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD | Photec Diagnostics, Inc. | 1989-04-26 | Traditional | PDF ↗ |
| K890990 | EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE | Hichem Diagnostics | 1989-04-10 | Traditional | PDF ↗ |
| K884757 | CLINISTAT CHOLESTEROL REAGENT TEST | Heraeus Kulzer, Inc. | 1989-03-10 | Traditional | PDF ↗ |
| K885023 | CHOLESTEROL TEST ITEM NUMBER: SR1011 | Em Diagnostic Systems, Inc. | 1989-02-17 | Traditional | PDF ↗ |
| K883543 | HDL-CHOLESTEROL PRECIPITATING REAGENT | Medical Analysis Systems, Inc. | 1988-12-16 | Traditional | PDF ↗ |
| K880723 | DIMENSION WHOLE BLOOD CHOLESTEROL | Technimed, Inc. | 1988-11-08 | Traditional | PDF ↗ |
| K883844 | HI CHEM KINETIC CHOLESTEROL REAGENT #88218 | Hichem Diagnostics | 1988-10-31 | Traditional | PDF ↗ |
| K864159 | SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD | Chem-Elec, Inc. | 1988-06-10 | Traditional | PDF ↗ |
| K880237 | CHOLESTEROL | Tech-Neal Scientific, Inc. | 1988-04-28 | Traditional | PDF ↗ |
| K880311 | WAKO(TM) AUTOKIT CHOLESTEROL | Wako Chemicals USA, Inc. | 1988-03-01 | Traditional | PDF ↗ |
| K875131 | (SKD) CHOLESTEROL TEST KIT | Smithkline Diagnostics, Inc. | 1988-03-01 | Traditional | PDF ↗ |
| K872930 | BIOTROL CHOLESTEROL ENZYMATIQUE COLOR | Biotrol, USA, Inc. | 1987-08-21 | Traditional | PDF ↗ |
| K872295 | CHOLESTEROL REAGENT | Sigma Diagnostics, Inc. | 1987-07-16 | Traditional | PDF ↗ |
| K872575 | HDL CHOLESTEROL REAGENT | Sigma Chemical Co. | 1987-07-16 | Traditional | PDF ↗ |
| K871676 | ENZYMATIC CHOLESTEROL REAGENT SET | Michclone Associates, Inc. | 1987-05-18 | Traditional | PDF ↗ |
| K870928 | CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS | Electro-Nucleonics Laboratories, Inc. | 1987-04-22 | Traditional | PDF ↗ |
| K871260 | CHOLESTEROL DETERMINATION | Biochemical Trade, Inc. | 1987-04-13 | Traditional | PDF ↗ |
| K870828 | INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT | Intersect Systems, Inc. | 1987-03-13 | Traditional | PDF ↗ |
| K870407 | EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607 | Em Diagnostic Systems, Inc. | 1987-03-04 | Traditional | PDF ↗ |
| K863103 | PEG 6,000 | J. D. Assoc. | 1987-01-13 | Traditional | PDF ↗ |
| K864081 | U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST | U. S. Diagnostics, Inc. | 1986-12-04 | Traditional | PDF ↗ |
| K863927 | CHOLESTEROL | Tech-Co, Inc. | 1986-11-24 | Traditional | PDF ↗ |
| K863252 | CHOLESTEROL PROCEDURE | Data Medical Associates, Inc. | 1986-09-29 | Traditional | PDF ↗ |
| K863062 | CHOLESTEROL-E (TOTAL) | J. D. Assoc. | 1986-09-25 | Traditional | PDF ↗ |
| K863064 | CHOLESTEROL-E (FREE) | J. D. Assoc. | 1986-09-11 | Traditional | PDF ↗ |
| K863063 | CHOLESTEROL-E FAST (TOTAL) | J. D. Assoc. | 1986-09-09 | Traditional | PDF ↗ |
| K862707 | EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95 | Em Diagnostic Systems, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K862507 | FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST) | Sclavo, Inc. | 1986-07-16 | Traditional | PDF ↗ |
| K861659 | CHOLESTEROL PROCEDURE | Data Medical Associates, Inc. | 1986-06-13 | Traditional | PDF ↗ |
| K861700 | DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM | E.I. Dupont DE Nemours & Co., Inc. | 1986-06-11 | Traditional | PDF ↗ |
| K860717 | ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL) | Trace Scientific , Ltd. | 1986-04-11 | Traditional | PDF ↗ |
| K855028 | TOTAL CHOLESTEROL REAGENT SET | Sterling Diagnostics, Inc. | 1986-01-28 | Traditional | PDF ↗ |
| K854426 | KODAK EKTACHEM HDL CHOLESTEROL KIT | Eastman Kodak Company | 1986-01-17 | Traditional | PDF ↗ |
| K855187 | ENZYMATIC CHOLESTROL REAGENT SET | Technostics Intl. | 1986-01-14 | Traditional | PDF ↗ |
| K854179 | IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL | Clinical Data, Inc. | 1985-11-25 | Traditional | PDF ↗ |
| K853854 | ASTRA SYSTEMS CHOLESTEROL REAGENT | Beckman Instruments, Inc. | 1985-10-28 | Traditional | PDF ↗ |
| K853871 | QCA ENZYMATIC CHOLESTEROL | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-10-04 | Traditional | PDF ↗ |
| K852863 | CHOLESTEROL METHOD | Catachem, Inc. | 1985-07-23 | Traditional | PDF ↗ |
| K850390 | CHOLESTEROL TEST SYSTEM | Hans J. Brouwers & Assoc. | 1985-07-09 | Traditional | PDF ↗ |
| K852009 | T-CHO REAGENT | Alpkem Corp. | 1985-05-30 | Traditional | PDF ↗ |
| K844655 | PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE | Boehringer Mannheim Corp. | 1985-01-07 | Traditional | PDF ↗ |
| K844242 | CHOLESTEROL REAGENT FOR DEMAND ANALYZER | Advanced Biomedical Methods, Inc. | 1985-01-03 | Traditional | PDF ↗ |
| K843222 | ENZYMATIC CHOLESTEROL KIT | Livonia Diagnostics, Inc. | 1984-09-28 | Traditional | PDF ↗ |
| K843510 | PDA CHOLESTEROL | Abbott Laboratories | 1984-09-28 | Traditional | PDF ↗ |
| K843327 | SYSTEMATE CHOLESTEROL 67222 | Em Diagnostic Systems, Inc. | 1984-09-14 | Traditional | PDF ↗ |
| K842160 | CHOLESTEROL ASSSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-08-17 | Traditional | PDF ↗ |
| K842320 | TDX REA CHOLESTEROL | Abbott Laboratories | 1984-08-15 | Traditional | PDF ↗ |
| K842441 | AXIOM STABLE II CHOLESTEROL TEST | Axiom, Inc. | 1984-07-25 | Traditional | PDF ↗ |
| K841182 | MULTIPLE CHEM. MODULE FOR ANALYSIS | Beckman Instruments, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K841053 | CHOLESTEROL REAGENT SET ENZYMATIC | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K840776 | PARAMAX CHOLESTEROL REAGENT | American Dade | 1984-04-04 | Traditional | PDF ↗ |
| K840368 | DURAZYME CHOLESTEROL | American Monitor Corp. | 1984-03-30 | Traditional | PDF ↗ |
| K840189 | TOTAL CHOLESTEROL REAGENT SET | Preventive Diagnostics Corp. | 1984-03-23 | Traditional | PDF ↗ |
| K832780 | FLOW-PAC SHOLESTEROL REAGENT SET | American Research Products Co. | 1983-10-14 | Traditional | PDF ↗ |
| K832158 | CHOLESTEROL HIGH PERFORMANCE-K | Boehringer Mannheim Corp. | 1983-08-16 | Traditional | PDF ↗ |
| K831863 | CHOLESTEROL-ENZYMATIC REAGENT SET | Stanbio Laboratory | 1983-07-22 | Traditional | PDF ↗ |
| K831700 | MULTICHEM ENZYMATIC CHOLESTEROL SYS | Simmler, Inc. | 1983-07-19 | Traditional | PDF ↗ |
| K831687 | WAKO CHOLESTEROL CII | Wako Chemicals USA, Inc. | 1983-07-18 | Traditional | PDF ↗ |
| K830761 | WAKO FREE CHOLESTEROL C TEST | Wako Chemicals USA, Inc. | 1983-04-18 | Traditional | PDF ↗ |
| K830239 | ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA | Emd Chemicals, Inc. | 1983-04-05 | Traditional | PDF ↗ |
| K830309 | ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE | Emd Chemicals, Inc. | 1983-02-28 | Traditional | PDF ↗ |
| K823784 | ENZYMATIC CHOLESTEROL (COLORIMETRIC | Analytical & Research Chemicals, Inc. | 1983-01-14 | Traditional | PDF ↗ |
| K823500 | CHOLESTEROL REAGENT | Ac Biochemical Laboratories, Inc. | 1982-12-30 | Traditional | PDF ↗ |
| K823354 | ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE | Emd Chemicals, Inc. | 1982-12-22 | Traditional | PDF ↗ |
| K823302 | CHOLESTEROL CHOD-PAP TEST | Boehringer Mannheim Corp. | 1982-12-09 | Traditional | PDF ↗ |
| K823187 | CHOLESTEROL HIGH SENSIT. REAGENT ENZYM | Rai, Inc. | 1982-11-22 | Traditional | PDF ↗ |
| K822417 | NEW ENZYMATIC SINGLE REAGENT FREE CHOL. | Sclavo, Inc. | 1982-10-21 | Traditional | PDF ↗ |
| K822418 | ULTRACHEM ENZYMATIC CHOL. OXIDASE | Emd Chemicals, Inc. | 1982-09-14 | Traditional | PDF ↗ |
| K821441 | ENZYMATIC CHOLESTERAL OXIDASE #650550 | Emd Chemicals, Inc. | 1982-06-01 | Traditional | PDF ↗ |
| K821105 | CHOLESTEZYME-V EIKEN | Syn-Kit, Inc. | 1982-05-05 | Traditional | PDF ↗ |
| K820950 | TOTAL CHOLESTEROL REAGENT SET | Sterling Biochemical, Inc. | 1982-04-26 | Traditional | PDF ↗ |
| K820951 | ENZYMATIC CHOLESTEROL KIT | Anco Medical Reagents & Assoc. | 1982-04-26 | Traditional | PDF ↗ |
| K820473 | ENZYMATIC CHOLESTEROL REAGENT SYSTEM | American Monitor Corp. | 1982-03-11 | Traditional | PDF ↗ |
| K820263 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES | Eastman Kodak Company | 1982-02-18 | Traditional | PDF ↗ |
| K813039 | ULTRACHEM E-CHOL, ITEM #65025 | Harleco | 1981-11-10 | Traditional | PDF ↗ |
| K812293 | CENTRICHEM CHOLESTEROL REAGENT & CALIBRA | Baker Diagnostics | 1981-08-31 | Traditional | PDF ↗ |
| K812091 | FAST CHOLES-CINET | Sclavo, Inc. | 1981-08-12 | Traditional | PDF ↗ |
| K812100 | SERALYZER | Miles Laboratories, Inc. | 1981-08-12 | Traditional | PDF ↗ |
| K811760 | CHOLESTEROL DETERMINATION | Biorent Diagnostic, Inc. | 1981-07-10 | Traditional | PDF ↗ |
| K810673 | ENZYMATIC CHOLESTEROL | Pointe Scientific, Inc., | 1981-03-31 | Traditional | PDF ↗ |
| K810405 | CHOLESTEROL REAGENT | Gilford Diagnostics | 1981-02-26 | Traditional | PDF ↗ |
| K803287 | CHOLESTEROL REAGENT ENZYMATIC | Rai, Inc. | 1981-01-16 | Traditional | PDF ↗ |
| K803254 | LIQUID-STAT REAGENT FOR ASSAY OF CHOLES. | Beckman Instruments, Inc. | 1981-01-09 | Traditional | PDF ↗ |
| K802743 | AMES SERA-PAK CHOLESTEROL REAGENT KIT | Miles Laboratories, Inc. | 1980-12-10 | Traditional | PDF ↗ |
| K801285 | YSI MODELS 23C & 23CM HDL & TOTAL CHOLES | Yellow Springs Instrument Co., Inc. | 1980-07-28 | Traditional | PDF ↗ |
| K801296 | COBAS REAGENT FOR CHOLESTEROL | Roche Analytical Instruments, Inc. | 1980-06-30 | Traditional | PDF ↗ |
| K800765 | CENTRIFICHEM CHOLESTEROL | Union Carbide Corp. | 1980-04-24 | Traditional | PDF ↗ |
| K800457 | LIQUID-STAT LIQUID REAGENT | Beckman Instruments, Inc. | 1980-03-20 | Traditional | PDF ↗ |
| K800199 | LINEAR ENZYMATIC CHOLESTEROL SYSTEM | Simmler, Inc. | 1980-02-21 | Traditional | PDF ↗ |
| K792509 | ACA HIGH DENSITY LIPOPROTEIN CHOLES. | E.I. Dupont DE Nemours & Co., Inc. | 1980-01-11 | Traditional | PDF ↗ |
| K792478 | CHEM-STRATE CHOLESTEROL | General Diagnostics | 1979-12-27 | Traditional | PDF ↗ |
| K791511 | ENZYMATIC REAGENT SET, 4X250 ML. | Macomb Chemical Co. | 1979-09-04 | Traditional | PDF ↗ |
| K790947 | AUTO ENZYMATIC CHOLESTEROL | Macomb Chemical Co. | 1979-06-28 | Traditional | PDF ↗ |
Product code CHH · Class I · Clinical Chemistry. Data: openFDA.