Cleared Abbreviated

DBEST HCG 2 IU/ML TEST KIT

K001215 · Ameritek, Inc. · Chemistry
Jun 2000
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K001215 is an FDA 510(k) clearance for the DBEST HCG 2 IU/ML TEST KIT, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Ameritek, Inc. (Seattle, US). The FDA issued a Cleared decision on June 22, 2000, 69 days after receiving the submission on April 14, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K001215 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2000
Decision Date June 22, 2000
Days to Decision 69 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

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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