510(k) K894524
- Device
- FPR GENTAMICIN CALIBRATOR KIT
- Applicant
- COLONY LABORATORIES, INC.
- 510(k) number
- K894524
- Product code
- DLG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-09-28
- Date received
- 1989-07-20
- Regulation
- 862.2250
- Classification name
- Coating, Liquid, Glc
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DALE B HINSON
- Address
- 1220 Nineteenth St., NW Fourth Floor Washington DC US 20036 20036
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 |
| 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#
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FDA Review#
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