FDA Product Code
FDA Product Code CEK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1635
510(k) Clearances — 116 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K792340 | CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE | Connecticut Diagnostics, Ltd. | 1979-12-06 | Traditional | PDF ↗ |
| K792346 | TWO MINUTE PROTEINTEST | Panmed, Inc. | 1979-12-06 | Traditional | PDF ↗ |
| K792138 | SMAC (SEQUENTIAL MULT. ANALYSIS COMP. | Fisher Scientific Co., LLC | 1979-11-13 | Traditional | PDF ↗ |
| K790808 | PROTEIN ASSAY KIT | Specialty Medical Industries, Inc. | 1979-11-05 | Traditional | PDF ↗ |
| K781897 | STAT KIT, MICROPROTEIN | Pierce Chemical Co. | 1979-01-10 | Traditional | PDF ↗ |
| K781774 | TOTAL PROTEIN | Gilford Diagnostics | 1978-11-22 | Traditional | PDF ↗ |
| K781722 | REAGENT SET, TOTAL PROTEIN | Medical Analysis Systems, Inc. | 1978-11-03 | Traditional | PDF ↗ |
| K772155 | ULTRACHEM TOTAL PROTEIN, #64974 | Harleco | 1977-12-06 | Traditional | PDF ↗ |
| K771926 | TOTAL PROTEIN SET, ITEM NO. 64010 | Harleco | 1977-11-11 | Traditional | PDF ↗ |
| K771841 | TOTAL PROTEIN | Gamma Enterprises, Inc. | 1977-10-25 | Traditional | PDF ↗ |
| K771476 | MULTISTAT III TOTAL PROTEIN TEST | Instrumentation Laboratory CO | 1977-09-12 | Traditional | PDF ↗ |
| K770887 | AUTO TOTAL PROTEIN FOR ANALYZER | Harleco | 1977-07-14 | Traditional | PDF ↗ |
| K770452 | PROTEIN PROCEDURE, TEKPOINT TOTAL | Icn Pharmaceuticals, Inc. | 1977-05-03 | Traditional | PDF ↗ |
| K761217 | AUTO TOTAL PROTEIN | Harleco | 1976-12-21 | Traditional | PDF ↗ |
| K761257 | AUTO TOTAL PROTEIN | Harleco | 1976-12-21 | Traditional | PDF ↗ |
| K760480 | REAGENT, TOTAL PROTEIN DETERMINATION | Simmler & Son, Inc. | 1976-10-29 | Traditional | PDF ↗ |
Product code CEK · Class II · Clinical Chemistry. Data: openFDA.