DELTA TROL I & II— 510(k) K853373
Substantially EquivalentElectro-Nucleonics Laboratories, Inc.
FDA 510(k) clearance K853373 for DELTA TROL I & II, Substantially Equivalent on 1985-08-23. Applicant: Electro-Nucleonics Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Electro-Nucleonics Laboratories, Inc.
- Product code
- Code JJT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbia, MD, US
Recent devices under product code JJT
view all- K090940 — SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
- K062751 — MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
- K030768 — CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
- K030102 — ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
- K021498 — LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
More clearances from Electro-Nucleonics Laboratories, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.