EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95— 510(k) K874101
Substantially EquivalentEm Diagnostic Systems, Inc.
FDA 510(k) clearance K874101 for EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95, Substantially Equivalent on 1987-11-09. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Em Diagnostic Systems, Inc.
- Product code
- Code DLJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3200
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gibbstown, NJ, US
Recent devices under product code DLJ
view all- K132090 — BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2
- K091617 — QMS LIDOCAINE CALIBRATORS, MODEL 0374678
- K082030 — DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440
- K062182 — DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520
- K062199 — DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)
More clearances from Em Diagnostic Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.