LD-1(IMMUNO) Separation Set
FDA 510(k) K851521 · Seragen Diagnostics, Inc.
510(k) numberK851521
Submission
- Device name
- LD-1(IMMUNO) Separation Set
- Applicant
- Seragen Diagnostics, Inc.
Indianapolis, IN, US - Received
- April 15, 1985
- Decision date
- May 10, 1985
- 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 |
|---|---|---|---|
| K872891 | Lactate Dehydrogenase Isoenzyme 1CEX · Traditional | Data Medical Associates, Inc. | 09/16/1987SE |
| 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 |
|---|---|---|
| K872148 | Vivid Chlamydia(Tm)LJC · Traditional | 08/19/1987SE |
| K851663 | Quick-Count Hematology ControlsJPK · Traditional | 07/23/1985SE |
| K852260 | Quick-Chem Calibration SetJIW · Traditional | 07/22/1985SE |
| K851520 | Ck/Ld Isoenzymes Controls(Human)JJT · Traditional | 06/25/1985SE |
| K850209 | Quick-LyteJGS · Traditional | 02/27/1985SE |
| K844743 | Seratest Ena(Rnp/Sm) DeterminationLLL · Traditional | 02/04/1985SE |
| K842563 | Seratest DNA DeterminationLKJ · Traditional | 10/25/1984SE |
| K841504 | Quick-Count Plus 2GKL · Traditional | 06/11/1984SE |
| K840793 | Ck/Mb Immuno-Isoenzyme Control SerumJJT · Traditional | 04/13/1984SE |
| K840863 | Seratest RF Latex DeterminationDHR · Traditional | 04/04/1984SE |
Questions and answers
When was LD-1(IMMUNO) Separation Set cleared by the FDA?
LD-1(IMMUNO) Separation Set (K851521) received a 510(k) decision of Substantially Equivalent on May 10, 1985, 25 days after the submission was received.
What is the product code of K851521?
The FDA product code is CEX – Chromatographic Separation, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.