INCSTAR RUBELLA IGG ELISA ASSAY— 510(k) K960367

Substantially Equivalent

Incstar Corp.

FDA 510(k) clearance K960367 for INCSTAR RUBELLA IGG ELISA ASSAY, Substantially Equivalent on 1996-10-24. Applicant: Incstar Corp.. Device class: 2.

Clearance details

Applicant: Incstar Corp.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1996-01-25
Decision date: 1996-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFX

K250588 — Access Rubella IgG2025-11-17
K243168 — Alinity i Rubella IgG2025-06-20
K122397 — LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM2012-09-06
K093101 — MAGO 4S2011-01-21
K092587 — BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM2010-12-03

More clearances from Incstar Corp.

K963289 — INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY1997-05-01
K963296 — INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)1996-12-16
K963297 — INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)1996-12-16
K960358 — INCSTAR RUBELLA IGG FAST ELISA ASSAY1996-10-24
K960434 — INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 85301996-10-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.