MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM— 510(k) K053571
Substantially EquivalentInterlab S.R.L.
FDA 510(k) clearance K053571 for MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, Substantially Equivalent on 2006-06-30. Applicant: Interlab S.R.L.. Device class: 2.
Clearance details
- Applicant
- Interlab S.R.L.
- Product code
- Code JBD
- Device class
- Class 2
- Regulation
- 21 CFR 864.7440
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Stroudsburg, PA, US
Recent devices under product code JBD
view all- K032862 — INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
- K992199 — ACID HEMOGLOBIN KIT
- K991362 — HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
- K982426 — SPIFE ALKALINE HEMOGLOBIN
- K931503 — REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
More clearances from Interlab S.R.L.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.