SPQ PAL CONTROL LEVEL II— 510(k) K934966

Substantially Equivalent

Incstar Corp.

FDA 510(k) clearance K934966 for SPQ PAL CONTROL LEVEL II, Substantially Equivalent on 1994-01-11. Applicant: Incstar Corp.. Device class: 1.

Clearance details

Applicant: Incstar Corp.
Product code: Code DDS
Device class: Class 1
Regulation: 21 CFR 866.5060
Advisory panel: Immunology
Date received: 1993-10-15
Decision date: 1994-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

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K960358 — INCSTAR RUBELLA IGG FAST ELISA ASSAY1996-10-24
K960367 — INCSTAR RUBELLA IGG ELISA ASSAY1996-10-24

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