Cleared Traditional

QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA

K853925 · Nms Pharmaceuticals, Inc. · Chemistry
Dec 1985
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K853925 is an FDA 510(k) clearance for the QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Nms Pharmaceuticals, Inc. (Newport Beach, US). The FDA issued a Cleared decision on December 2, 1985, 69 days after receiving the submission on September 24, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K853925 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 1985
Decision Date December 02, 1985
Days to Decision 69 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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