Lactate Dehydrogenase Isoenzyme 1
FDA 510(k) K872891 · Data Medical Associates, Inc.
510(k) numberK872891
Submission
- Device name
- Lactate Dehydrogenase Isoenzyme 1
- Applicant
- Data Medical Associates, Inc.
Arlington, TX, US - Received
- July 23, 1987
- Decision date
- September 16, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEX – Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1445
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CEX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K851521 | LD-1(IMMUNO) Separation SetCEX · Traditional | Seragen Diagnostics, Inc. | 05/10/1985SE |
| K842018 | Iso-Sep SystemCEX · Traditional | Berwick Medical Products, Inc. | 09/28/1984SE |
| K821983 | Titan Gel LDH Isoenzyme KitCEX · Traditional | Helena Laboratories | 12/22/1982SE |
| K821879 | Ultrachem T.P.CEX · Traditional | Harleco Diagnostics | 07/14/1982SE |
| K800129 | Centrifichem CreatinineCEX · Traditional | Union Carbide Corp. | 02/13/1980SE |
| K772356 | LDH Isoenzyme Column Reagent SetCEX · Traditional | Worthington Biochemical Corp. | 01/24/1978SE |
| K771894 | LDH Isoenzyme ControlCEX · Traditional | Bio-Reagents & Diagnostics, Inc. | 12/22/1977SE |
More from Bio-Reagents & Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K993098 | Hdl-C/Ldl-C Calibrator, Model 1913-003JIX · Traditional | 10/08/1999SE |
| K971113 | Dma Triglycerides ProceduresCDT · Traditional | 05/29/1997SE |
| K961919 | Dma Gamma Glutamyltransferase (GGT) ProcedureJPZ · Traditional | 07/01/1996SE |
| K955796 | Iron Calibrator & Calibration Verification SetJJX · Traditional | 02/29/1996SE |
| K955302 | Serum Bicarbonate/Carbon DioxideKHS · Traditional | 02/29/1996SE |
| K955300 | Total Bilirubin ProcedureCIG · Traditional | 12/20/1995SE |
| K952437 | Dma Glucose Hexokinase U.V. ProcedureCFR · Traditional | 10/03/1995SE |
| K946161 | Dma Total Cholesterol ProcedureCHH · Traditional | 08/23/1995SE |
| K946354 | Dma Unsaturated Iron Binding Capacity ProcedureJMO · Traditional | 05/08/1995SE |
| K946355 | Dma Albumin ProcedureCIX · Traditional | 03/01/1995SE |
Questions and answers
When was Lactate Dehydrogenase Isoenzyme 1 cleared by the FDA?
Lactate Dehydrogenase Isoenzyme 1 (K872891) received a 510(k) decision of Substantially Equivalent on September 16, 1987, 55 days after the submission was received.
What is the product code of K872891?
The FDA product code is CEX – Chromatographic Separation, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.