ICON READER— 510(k) K862956

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K862956 for ICON READER, Substantially Equivalent on 1986-08-19. Applicant: Hybritech, Inc.. Device class: 1.

Clearance details

Applicant: Hybritech, Inc.
Product code: Code JQT
Device class: Class 1
Regulation: 21 CFR 862.2400
Advisory panel: Clinical Chemistry
Date received: 1986-08-05
Decision date: 1986-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JQT

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K915332 — MODEL 795 FLUOROMETER/DENSITOMETER1992-02-18
K885254 — TARGET READER1989-01-27
K860645 — ELECTROPHORESIS DATA CENTER (EDC)1986-12-17

More clearances from Hybritech, Inc.

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K930810 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY1994-01-11
K922754 — TANDEM-E IGE II CALIBRATION VERIFICATION SET1993-02-17
K921745 — HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO1992-07-30

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