Ultrachem T.P.
FDA 510(k) K821879 · Harleco Diagnostics
510(k) numberK821879
Submission
- Device name
- Ultrachem T.P.
- Applicant
- Harleco Diagnostics
Mchenry, IL, US - Received
- June 25, 1982
- Decision date
- July 14, 1982
- 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 |
| 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 |
|---|---|---|
| K823147 | Uric Acid Standard, 8MG/DL #65078JIS · Traditional | 11/22/1982SE |
| K822852 | Triglyceride CalibratorJIT · Traditional | 10/27/1982SE |
| K822323 | Ultrachem Bun-Uv, 65080 & 65081CDW · Traditional | 09/02/1982SE |
| K821883 | Ultrazyme Plus Ck-ICGS · Traditional | 07/14/1982SE |
| K821882 | Ultrazyme Plus GPTCKA · Traditional | 07/14/1982SE |
| K821881 | Ultrachem CreaCGX · Traditional | 07/14/1982SE |
| K821880 | Ultra Chem AlbCIX · Traditional | 07/14/1982SE |
| K821878 | Ultrazyme Plus LDHCFJ · Traditional | 07/14/1982SE |
| K821877 | Ultrazyme Plus HBDJMK · Traditional | 07/14/1982SE |
| K821873 | Ultrachem T-BiliCIG · Traditional | 07/14/1982SE |
Questions and answers
When was Ultrachem T.P. cleared by the FDA?
Ultrachem T.P. (K821879) received a 510(k) decision of Substantially Equivalent on July 14, 1982, 19 days after the submission was received.
What is the product code of K821879?
The FDA product code is CEX – Chromatographic Separation, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.