Cleared Traditional

ROCHE(R) B-HCG RIA URINE STANDARD

K820942 · Hoffmann-La Roche, Inc. · Chemistry
May 1982
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K820942 is an FDA 510(k) clearance for the ROCHE(R) B-HCG RIA URINE STANDARD, 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 May 3, 1982, 27 days after receiving the submission on April 6, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K820942 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 1982
Decision Date May 03, 1982
Days to Decision 27 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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