FDA Product Code
FDA Product Code CJE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1050
510(k) Clearances — 124 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K800679 | REAGENTS FOR DETERM. ALKALINE PHOSPHATAS | Diagnostic Solutions, Inc. | 1980-05-28 | Traditional | PDF ↗ |
| K800131 | CENTRIFICHEM ALP/ALKALINE PHOSPHATASE | Union Carbide Corp. | 1980-02-11 | Traditional | PDF ↗ |
| K792413 | ELVI ALKALINE PHOSPHATATASE | Volu Sol Medical Industries | 1979-12-07 | Traditional | PDF ↗ |
| K790065 | ALKALINE PHOSPHATASE | Macomb Chemical Co. | 1979-02-21 | Traditional | PDF ↗ |
| K781718 | ALP REAGENT SET, ALKALINE PHOSPHATASE | Medical Analysis Systems, Inc. | 1978-11-03 | Traditional | PDF ↗ |
| K781609 | ALKALINE PHOSPHATASE IN SERUM | Fisher Scientific Co., LLC | 1978-10-24 | Traditional | PDF ↗ |
| K781472 | MITROPHENYL, ALKALINE PHOSPHATES | Beckman Instruments, Inc. | 1978-09-27 | Traditional | PDF ↗ |
| K780095 | ULTRAZYME PLUS ALP | Harleco | 1978-02-13 | Traditional | PDF ↗ |
| K780068 | ALP REAGENT SET | Medical Analysis Systems, Inc. | 1978-02-07 | Traditional | PDF ↗ |
| K772032 | GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP | Harleco | 1977-11-17 | Traditional | PDF ↗ |
| K771829 | ALKALINE PHOSPHATASE | Gamma Enterprises, Inc. | 1977-11-02 | Traditional | PDF ↗ |
| K771695 | ALKALINE PHOSPHATASE TEST | Sclavo, Inc. | 1977-10-18 | Traditional | PDF ↗ |
| K771470 | MULTISTAT III ALKALINE PHOSPHATASE | Instrumentation Laboratory CO | 1977-09-12 | Traditional | PDF ↗ |
| K771085 | DYNAZYME II ALKALINE PHOSPHATASE | J.T. Baker Chemical Co. | 1977-08-04 | Traditional | PDF ↗ |
| K770870 | ULTRAZYME PLUS ALP | Harleco | 1977-07-14 | Traditional | PDF ↗ |
| K770406 | TECHNICON SMA & AAII SYSTEMS | Boehringer Laboratories | 1977-06-02 | Traditional | PDF ↗ |
| K770316 | ALKALINE PHOSPHATASE ENZYMATIC | Icn Pharmaceuticals, Inc. | 1977-03-30 | Traditional | PDF ↗ |
| K761315 | ALKALINE PHOSPHATASE (ALP)/PNPP | Princeton Biomedix | 1977-02-24 | Traditional | PDF ↗ |
| K760685 | SIGMA PROCED #SC165 | Sigma Chemical Co. | 1976-11-24 | Traditional | PDF ↗ |
| K760397 | REAGENT, AMP BUFFER DIAGNOSTIC | J.T. Baker Chemical Co. | 1976-11-01 | Traditional | PDF ↗ |
| K760398 | REAGENT, MAGNESIUM CHLORIDE | J.T. Baker Chemical Co. | 1976-10-29 | Traditional | PDF ↗ |
| K760474 | REAGENT, ALKALINE PHOSPHATASE DETERM. | Simmler & Son, Inc. | 1976-10-29 | Traditional | PDF ↗ |
| K760399 | REAGENT, P-NITROPHENYL PHOSPHATE | J.T. Baker Chemical Co. | 1976-08-26 | Traditional | PDF ↗ |
| K760024 | ULTRAZYME ALKALINE PHOSPHATASE | Harleco | 1976-08-26 | Traditional | PDF ↗ |
Product code CJE · Class II · Clinical Chemistry. Data: openFDA.