Cleared Traditional

ROCHE B-HCG STANDARDS

K820614 · Hoffmann-La Roche, Inc. · Chemistry
Apr 1982
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K820614 is an FDA 510(k) clearance for the ROCHE B-HCG STANDARDS, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 1, 1982, 24 days after receiving the submission on March 8, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K820614 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 1982
Decision Date April 01, 1982
Days to Decision 24 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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