Cleared Traditional

TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY

K865057 · Hybritech, Inc. · Chemistry
Mar 1987
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K865057 is an FDA 510(k) clearance for the TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on March 10, 1987, 76 days after receiving the submission on December 24, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K865057 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 1986
Decision Date March 10, 1987
Days to Decision 76 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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