Product code DLG— Clinical Chemistry
EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95
- Classification name
- Coating, Liquid, Glc
- Device class
- Class 1
- Regulation
- 21 CFR 862.2250
- Advisory panel
- Clinical Chemistry
- Total cleared
- 7
- First cleared
- Most recent
Market context for product code DLG
FDA has cleared devices under product code DLG between 1983 and 2006, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2006
- 1992
- 1989
- 1988
- 1983
Top applicants under product code DLG
Recent clearances under product code DLG
- K050988 — OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
- K920419 — IL TEST DAT CAL/CONTROL SET D/E
- K894518 — FPR AMIKACIN CALIBRATOR KIT
- K894524 — FPR GENTAMICIN CALIBRATOR KIT
- K894528 — FPR PHENYTOIN CALIBRATOR KIT
- K882766 — EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95
- K833385 — N-ACETYLPROCAINAMIDE CALIBRATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.