LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668— 510(k) K884548
Substantially EquivalentEm Diagnostic Systems, Inc.
FDA 510(k) clearance K884548 for LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668, Substantially Equivalent on 1988-11-10. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Em Diagnostic Systems, Inc.
- Product code
- Code CFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1440
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gibbstown, NJ, US
Recent devices under product code CFJ
view all- K131975 — ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
- K091544 — S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
- K051108 — PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM
- K974859 — LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
- K973589 — LIQUID LDH-L REAGENT SET
More clearances from Em Diagnostic Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.