ENCORE FERRITIN REAGENT— 510(k) K850680

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K850680 for ENCORE FERRITIN REAGENT, Substantially Equivalent on 1985-03-21. Applicant: Hybritech, Inc.. Device class: 2.

Clearance details

Applicant: Hybritech, Inc.
Product code: Code JMB
Device class: Class 2
Regulation: 21 CFR 864.7360
Advisory panel: Hematology
Date received: 1985-02-21
Decision date: 1985-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

More clearances from Hybritech, Inc.

K972666 — TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY1997-09-11
K961573 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY1996-08-19
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.