FPR PHENYTOIN CALIBRATOR KIT
FDA 510(k) clearance K894528 · decided 1989-09-25
Clearance details
- K-number
- K894528
- Device name
- FPR PHENYTOIN CALIBRATOR KIT
- Applicant
- Colony Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-20
- Decision date
- 1989-09-25
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- DLG
- Device class
- 1
- Regulation number
- 862.2250
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Colony Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS (K050988) | Lin-Zhi International, Inc. | 2006-04-06 |
| 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 |
| 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.