Cleared Special

HCG STAT PAK ULTRA-FAST

K011550 · Chembio Diagnostic Systems, Inc. · Chemistry
Aug 2001
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K011550 is an FDA 510(k) clearance for the HCG STAT PAK ULTRA-FAST, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Chembio Diagnostic Systems, Inc. (Beverly, US). The FDA issued a Cleared decision on August 14, 2001, 88 days after receiving the submission on May 18, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K011550 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2001
Decision Date August 14, 2001
Days to Decision 88 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

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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