Cleared Traditional

TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY

K870521 · Hybritech, Inc. · Chemistry
Apr 1987
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K870521 is an FDA 510(k) clearance for the TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. 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 April 8, 1987, 61 days after receiving the submission on February 6, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K870521 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 1987
Decision Date April 08, 1987
Days to Decision 61 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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