OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
FDA 510(k) clearance K050988 · decided 2006-04-06
Clearance details
- K-number
- K050988
- Device name
- OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
- Applicant
- Lin-Zhi International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-04-19
- Decision date
- 2006-04-06
- Days to decision
- 352 days
- Clearance type
- Traditional
- Product code
- DLG
- Device class
- 1
- Regulation number
- 862.2250
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Synnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IL TEST DAT CAL/CONTROL SET D/E (K920419) | Instrumentation Laboratory CO | 1992-03-11 |
| FPR GENTAMICIN CALIBRATOR KIT (K894524) | Colony Laboratories, Inc. | 1989-09-28 |
| FPR AMIKACIN CALIBRATOR KIT (K894518) | Colony Laboratories, Inc. | 1989-09-28 |
| FPR PHENYTOIN CALIBRATOR KIT (K894528) | Colony Laboratories, Inc. | 1989-09-25 |
| EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 (K882766) | Em Diagnostic Systems, Inc. | 1988-08-23 |
| N-ACETYLPROCAINAMIDE CALIBRATOR (K833385) | E.I. Dupont DE Nemours & Co., Inc. | 1983-12-16 |
Recalls involving this device
No recalls on record reference this clearance.