FDA product code JOB: Hexane Extraction, Fluorescence, Vitamin E

JOB is the FDA product code for hexane extraction, fluorescence, vitamin e. It is a Class I device, regulated under 21 CFR 862.1815 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JOB. The average 510(k) review took 239 days (median 239).

Classification

FieldValue
Device nameHexane Extraction, Fluorescence, Vitamin E
Device classClass I
Regulation21 CFR 862.1815
Review panelCH — Clinical Chemistry
Medical specialtyClinical Chemistry
Premarket route510(k) exempt

Compare with all 510(k) review times · Search every JOB clearance

Top JOB applicants

ApplicantClearancesLatest
D. E. Hokanson, Inc.11994-02-04

Most recent JOB clearances

510(k)ApplicantDeviceDecision dateReview days
K932852D. E. Hokanson, Inc.NON INVASIVE VASCULAR PROGRAM1994-02-04239

Recalls for JOB devices

openFDA lists no recalls for product code JOB.

Frequently asked questions

What is FDA product code JOB?

JOB is the FDA product code for hexane extraction, fluorescence, vitamin e. It is a Class I device, regulated under 21 CFR 862.1815 and reviewed by the Clinical Chemistry panel.

What device class is JOB?

Class I, regulation 21 CFR 862.1815. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code JOB?

Across 1 cleared submissions the average was 239 days from receipt to decision (median 239).

Which companies have the most JOB clearances?

D. E. Hokanson, Inc. (1).

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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