CEK — Biuret (Colorimetric), Total Protein Class II
FDA product code CEK covers "Biuret (Colorimetric), Total Protein", a Class II medical device regulated under 21 CFR 862.1635. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CEK
- Device Class
- Class II
- Regulation Number
- 862.1635
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K992846 | elan holdings | HICHEM TOTAL PROTEIN REAGENT | October 18, 1999 |
| K973108 | diagnostic chemicals | TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 | March 2, 1998 |
| K980042 | exigent diagnostics | CARESIDE TOTAL PROTEIN | February 4, 1998 |
| K971524 | carolina liquid chemistries | TOTAL PROTEIN OR TP | May 16, 1997 |
| K961864 | teco diagnostics | CSF/URINE TOTAL PROTEIN | October 24, 1996 |
| K955905 | solarcare technologies corp | STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY | May 30, 1996 |
| K955936 | derma media lab | TOTAL PROTEIN REAGENT | March 12, 1996 |
| K950920 | dupont medical products | DUPONT DIMENSION TOTAL PROTEIN METHOD | August 11, 1995 |
| K950234 | emd chemicals | TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 | June 14, 1995 |
| K950128 | emd chemicals | TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 | May 15, 1995 |
| K943004 | prisma systems | TOTAL PROTEIN QVET | December 9, 1994 |
| K941496 | solarcare | SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY | October 27, 1994 |
| K942424 | data medical associates | DMA MICROPROTEIN PROCEDURE | September 6, 1994 |
| K934841 | e.i. dupont de nemours and co | URINARY/CEREBROSPINAL FLUID PROTEIN | April 6, 1994 |
| K935174 | em diagnostic systems | TOTAL PROTEIN TEST (TPRO) | December 16, 1993 |
| K921412 | sterling diagnostics | MICROPROTEIN REAGENT SET | January 21, 1993 |
| K924659 | olympus | OLYUMPUS TOTAL PROTEIN REAGENT | December 29, 1992 |
| K922467 | beckman instruments | SYNCHRON TOTAL PROTEIN TEST --MODIFIED | November 23, 1992 |
| K923267 | em diagnostic systems | SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000 | September 9, 1992 |
| K923266 | nova biomedical | NOVA TOTAL PROTEIN MODULE | August 12, 1992 |