FDA Product Code
FDA Product Code CDT — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1705
510(k) Clearances — 151 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K832426 | EASYTOUCH TRIGLYCERIDES REAGENT SET | Worthington Diagnostic Systems | 1983-09-12 | Traditional | PDF ↗ |
| K832444 | ENZYMATIC TRIGLYCERIDES #2000 | Stanbio Laboratory | 1983-08-31 | Traditional | PDF ↗ |
| K831858 | TRIGLYCERIDES REAGENT SET | Stanbio Laboratory | 1983-07-22 | Traditional | PDF ↗ |
| K830288 | TRIGLYCERIDE DIAGNOSTIC KIT | Sclavo, Inc. | 1983-02-25 | Traditional | PDF ↗ |
| K823709 | TRIGLYCERIDE REAGENT (UV) | Gilford Diagnostics | 1983-01-07 | Traditional | PDF ↗ |
| K823341 | TRIGLYCERIDES REAGENT SET TAG-GK | Sterling Biochemical, Inc. | 1982-12-22 | Traditional | PDF ↗ |
| K821205 | TRIGLYCERIDE REAGENT SET | Omega Medical Electronics | 1982-07-20 | Traditional | PDF ↗ |
| K821875 | ULTRACHEM TRI-ES | Harleco Diagnostics | 1982-07-13 | Traditional | PDF ↗ |
| K821315 | DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM | The Dow Chemical Co. | 1982-05-24 | Traditional | PDF ↗ |
| K812838 | TRIGLYCERIDE REAGENT SET | Anco Medical Reagents & Assoc. | 1981-12-03 | Traditional | PDF ↗ |
| K812589 | ULTRA CHEM E-TRIG #65024 | Harleco | 1981-09-24 | Traditional | PDF ↗ |
| K812471 | SPIN-CHEM TRIGLYCERIDES REAGENT | Smithkline Diagnostics, Inc. | 1981-09-14 | Traditional | PDF ↗ |
| K812029 | KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG) | Eastman Kodak Company | 1981-08-03 | Traditional | PDF ↗ |
| K811850 | ESKAFLOW TEST FOR TRIGLYCERIDES | Smithkline Diagnostics, Inc. | 1981-07-23 | Traditional | PDF ↗ |
| K810965 | DATA-ZYME TRIGLYCERIDE | Data Medical Associates, Inc. | 1981-04-17 | Traditional | PDF ↗ |
| K810680 | ENZYMATIC TRIGLYCERIDE | Pointe Scientific, Inc., | 1981-03-31 | Traditional | PDF ↗ |
| K803297 | LUQUIZYME TRIGLYCERIDE REAGENT SET | Amresco, Inc. | 1981-01-16 | Traditional | PDF ↗ |
| K803091 | TRIGLYCERIDES (UV)-2 REAGENTS | Reagents Applications, Inc. | 1981-01-09 | Traditional | PDF ↗ |
| K802256 | TRIGLYCERIDES DETERMINATION | Coleman Laboratories Corp. | 1980-10-23 | Traditional | PDF ↗ |
| K802136 | DELTA TEST TRIGLYCERIDES | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-10-10 | Traditional | PDF ↗ |
| K801891 | WAKO TRIGLYCERIDE-G TEST | Wako Pure Chemical Industries, Ltd. | 1980-09-16 | Traditional | PDF ↗ |
| K801298 | COBAS REAGENT FOR TRIGLYCERIDES & COBAS | Roche Analytical Instruments, Inc. | 1980-07-08 | Traditional | PDF ↗ |
| K801226 | TRIGLYCERIDES FOR SMA AND AAII | Reagents Applications, Inc. | 1980-06-20 | Traditional | PDF ↗ |
| K800649 | ENZYMATIC TRIGLYCERIDES REAFENT FOR SMAC | Reagents Applications, Inc. | 1980-05-08 | Traditional | PDF ↗ |
| K800301 | SIGMA PROCEDURE & REAGENT SYSTEM #335-UV | Sigma Chemical Co. | 1980-03-05 | Traditional | PDF ↗ |
| K792480 | CHEM-STRATE TRIGLYCERIDE | General Diagnostics | 1979-12-27 | Traditional | PDF ↗ |
| K792234 | SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES | Boehringer Mannheim Corp. | 1979-11-27 | Traditional | PDF ↗ |
| K791640 | COULTER ACCU-ZYME II ENZYMATIC REAGENT | Coulter Electronics, Inc. | 1979-09-24 | Traditional | PDF ↗ |
| K791597 | WAKO TRIGLYCERIDE | Wako Pure Chemical Industries, Ltd. | 1979-09-17 | Traditional | PDF ↗ |
| K790773 | ENZYMATIC TRIGLYCERIDES-S.V.R. | Calbiochem-Behring Corp. | 1979-06-15 | Traditional | PDF ↗ |
| K781939 | REAGENT KIT, TRIGLYCERIDES | Beckman Instruments, Inc. | 1979-01-10 | Traditional | PDF ↗ |
| K781477 | TRIGLYCERIDES TEST KIT | Mallinckrodt Critical Care | 1978-10-03 | Traditional | PDF ↗ |
| K781466 | AUTOMATED ENZYMATIC TRIGLYCERIDE REAGENT | Fisher Scientific Co., LLC | 1978-10-03 | Traditional | PDF ↗ |
| K781240 | ENZYMATIC TRIGLYCERIDES REAGENT KIT | J.T. Baker Chemical Co. | 1978-08-17 | Traditional | PDF ↗ |
| K780379 | DATA-ZYME TRIGLYCERIDE PROCEDURE | Data Medical Associates, Inc. | 1978-05-12 | Traditional | PDF ↗ |
| K780172 | TRIGLYCERIDE INSTRUMENT APPLICATION | Harleco | 1978-03-09 | Traditional | PDF ↗ |
| K771905 | GLYCEROL SUBSTRATE | Simmler & Son, Inc. | 1977-12-06 | Traditional | PDF ↗ |
| K771906 | PHOSPHATE | Simmler & Son, Inc. | 1977-12-06 | Traditional | PDF ↗ |
| K771904 | GLYCEROL KINASE | Simmler & Son, Inc. | 1977-12-06 | Traditional | PDF ↗ |
| K771903 | LIPASE | Simmler & Son, Inc. | 1977-12-06 | Traditional | PDF ↗ |
| K771608 | A-GENT TRIGLYCERIDES | Abbott Laboratories | 1977-09-15 | Traditional | PDF ↗ |
| K771004 | AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI | Miles Laboratories, Inc. | 1977-09-12 | Traditional | PDF ↗ |
| K771472 | MULTISTAT III TRIGLYCERIDE TEST | Instrumentation Laboratory CO | 1977-09-02 | Traditional | PDF ↗ |
| K770993 | TRIGLYCERIDE REAGENT SET | Macomb Chemical Co. | 1977-09-02 | Traditional | PDF ↗ |
| K770841 | TRIGLYCERIDE ENZYMATIC METHOD | Union Carbide Corp. | 1977-07-14 | Traditional | PDF ↗ |
| K761262 | TRIGLYCERIDES (LIPASE) REAGENT SET | Worthington Biochemical Corp. | 1976-12-29 | Traditional | PDF ↗ |
| K761200 | ENZYMATIC TRIGLYCERIDES (END POINT) | Beckman Instruments, Inc. | 1976-12-21 | Traditional | PDF ↗ |
| K760713 | TRIGLYCERIDES TEST | Boehringer Mannheim Corp. | 1976-11-29 | Traditional | PDF ↗ |
| K760029 | ENZYMATIC TRIGLYCERIDE | Harleco | 1976-09-15 | Traditional | PDF ↗ |
| K760195 | REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1 | Coulter Electronics, Inc. | 1976-08-03 | Traditional | PDF ↗ |
| K760011 | REAGENT, TRIGLYCERIDES | The Dow Chemical Co. | 1976-07-26 | Traditional | PDF ↗ |
Product code CDT · Class I · Clinical Chemistry. Data: openFDA.