Cleared Traditional

BHCG-ROCHE EIA

K850727 · Hoffmann-La Roche, Inc. · Chemistry
Jun 1985
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K850727 is an FDA 510(k) clearance for the BHCG-ROCHE EIA, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Hoffmann-La Roche, Inc. (Nutley, US). The FDA issued a Cleared decision on June 25, 1985, 123 days after receiving the submission on February 22, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K850727 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 1985
Decision Date June 25, 1985
Days to Decision 123 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JHI — Visual, Pregnancy Hcg, Prescription Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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