510(k) K833385
- Device
- N-acetylprocainamide Calibrator
- Applicant
- E.I. DUPONT DE NEMOURS & CO., INC.
- 510(k) number
- K833385
- Product code
- DLG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-12-16
- Date received
- 1983-09-29
- Regulation
- 862.2250
- Classification name
- Coating, Liquid, Glc
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2242547
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DLG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050988 | OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | 2006-04-06 |
| K920419 | IL TEST DAT CAL/CONTROL SET D/E | Instrumentation Laboratory CO | 1992-03-11 |
| K894518 | FPR AMIKACIN CALIBRATOR KIT | Colony Laboratories, Inc. | 1989-09-28 |
| K894524 | FPR GENTAMICIN CALIBRATOR KIT | Colony Laboratories, Inc. | 1989-09-28 |
| K894528 | FPR PHENYTOIN CALIBRATOR KIT | Colony Laboratories, Inc. | 1989-09-25 |
| K882766 | EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 | Em Diagnostic Systems, Inc. | 1988-08-23 |