LDH Isoenzyme Column Reagent Set
FDA 510(k) K772356 · Worthington Biochemical Corp.
510(k) numberK772356
Submission
- Device name
- LDH Isoenzyme Column Reagent Set
- Applicant
- Worthington Biochemical Corp.
Mchenry, IL, US - Received
- December 27, 1977
- Decision date
- January 24, 1978
- 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 |
| 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 |
| K771894 | LDH Isoenzyme ControlCEX · Traditional | Bio-Reagents & Diagnostics, Inc. | 12/22/1977SE |
More from Bio-Reagents & Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K780389 | HDL Reagent Set for LipoproteinsCHH · Traditional | 04/19/1978SE |
| K780096 | LDH Isoenzyme Control SerumJJY · Traditional | 03/03/1978SE |
| K772025 | Uric Acid Std. for Quant. Uric AcidJIS · Traditional | 11/11/1977SE |
| K771143 | Inorganic Phosphorus StandardsJIT · Traditional | 07/11/1977SE |
| K771001 | Statzyme GlucoseCGA · Traditional | 07/11/1977SE |
| K770831 | Statzyme Uric Acid ReagentCDO · Traditional | 07/11/1977SE |
| K770470 | Worthington BunCDW · Traditional | 06/02/1977SE |
| K770277 | Cholesterol StandardsJIT · Traditional | 03/01/1977SE |
| K761263 | Cholesterol Automated ReagentCHH · Traditional | 12/29/1976SE |
| K761262 | Triglycerides (Lipase) Reagent SetCDT · Traditional | 12/29/1976SE |
Questions and answers
When was LDH Isoenzyme Column Reagent Set cleared by the FDA?
LDH Isoenzyme Column Reagent Set (K772356) received a 510(k) decision of Substantially Equivalent on January 24, 1978, 28 days after the submission was received.
What is the product code of K772356?
The FDA product code is CEX – Chromatographic Separation, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.