Centrifichem Creatinine
FDA 510(k) K800129 · Union Carbide Corp.
510(k) numberK800129
Submission
- Device name
- Centrifichem Creatinine
- Applicant
- Union Carbide Corp.
Mchenry, IL, US - Received
- January 18, 1980
- Decision date
- February 13, 1980
- 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 |
| 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 |
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| K820535 | Laser Gas MixturesEWG · Traditional | 03/31/1982SE |
| K812536 | Linde Mark IIBYJ · Traditional | 09/23/1981SE |
| K810732 | Linde Mark II Oxygen Reserv. Type OR-4BYJ · Traditional | 03/27/1981SE |
| K810596 | Centrifi Chem System 400 AnalyzerJJE · Traditional | 03/17/1981SE |
| K810129 | Centrifichem System 500JJE · Traditional | 02/02/1981SE |
| K803216 | Centrifichem Ast/Sgot Optimized ReagentCIT · Traditional | 01/09/1981SE |
| K802741 | Centrifichem Comb. Serum-Based Calib.JIX · Traditional | 12/10/1980SE |
| K802520 | Centrifichem Pipettor Accuracy Calib.JQW · Traditional | 11/12/1980SE |
Questions and answers
When was Centrifichem Creatinine cleared by the FDA?
Centrifichem Creatinine (K800129) received a 510(k) decision of Substantially Equivalent on February 13, 1980, 26 days after the submission was received.
What is the product code of K800129?
The FDA product code is CEX – Chromatographic Separation, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.