EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93— 510(k) K872321
Substantially EquivalentEm Diagnostic Systems, Inc.
FDA 510(k) clearance K872321 for EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93, Substantially Equivalent on 1987-08-28. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Em Diagnostic Systems, Inc.
- Product code
- Code DKJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3830
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gibbstown, NJ, US
Recent devices under product code DKJ
view all- K093939 — ADVIA CHEMISTRY SALICYLATE REAGENT
- K042329 — SALICYLATE-SL ASSAY
- K020794 — SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- K014173 — SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
- K011878 — EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
More clearances from Em Diagnostic Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.