FDA Product Code
FDA Product Code DLG — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.2250
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K050988 | OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | 2006-04-06 | Traditional | PDF ↗ |
| K920419 | IL TEST DAT CAL/CONTROL SET D/E | Instrumentation Laboratory CO | 1992-03-11 | Traditional | PDF ↗ |
| K894524 | FPR GENTAMICIN CALIBRATOR KIT | Colony Laboratories, Inc. | 1989-09-28 | Traditional | PDF ↗ |
| K894518 | FPR AMIKACIN CALIBRATOR KIT | Colony Laboratories, Inc. | 1989-09-28 | Traditional | PDF ↗ |
| K894528 | FPR PHENYTOIN CALIBRATOR KIT | Colony Laboratories, Inc. | 1989-09-25 | Traditional | PDF ↗ |
| K882766 | EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 | Em Diagnostic Systems, Inc. | 1988-08-23 | Traditional | PDF ↗ |
| K833385 | N-ACETYLPROCAINAMIDE CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1983-12-16 | Traditional | PDF ↗ |
Product code DLG · Class I · Clinical Chemistry. Data: openFDA.