510(k) K050988
- Device
- OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
- Applicant
- Lin-Zhi International, Inc.
- 510(k) number
- K050988
- Product code
- DLG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-04-06
- Date received
- 2005-04-19
- Regulation
- 862.2250
- Classification name
- Coating, Liquid, Glc
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARIE LIN
- Address
- 687 N. Pastoria Ave. Synnyvale CA US 94085 94085
FDA Registration Numbers#
- 2242547
Source Documents#
Other 510(k) Records For Product Code DLG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K833385 | N-ACETYLPROCAINAMIDE CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1983-12-16 |
Legacy Summary#
summary
FDA Review#
Decision Summary