Cleared Traditional

TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY

K864945 · Hybritech, Inc. · Chemistry
Jan 1987
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K864945 is an FDA 510(k) clearance for the TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY, a Acid Phosphatase (prostatic), Tartrate Inhibited (Class II — Special Controls, product code JFH), submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on January 5, 1987, 19 days after receiving the submission on December 17, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number K864945 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 1986
Decision Date January 05, 1987
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JFH — Acid Phosphatase (prostatic), Tartrate Inhibited
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1020

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