Cleared Traditional

DBEST ONE-STEP HCG SERUM/URINE TEST

K973957 · Ameritek, Inc. · Chemistry
Dec 1997
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K973957 is an FDA 510(k) clearance for the DBEST ONE-STEP HCG SERUM/URINE TEST, 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 December 17, 1997, 62 days after receiving the submission on October 16, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K973957 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 1997
Decision Date December 17, 1997
Days to Decision 62 days
Submission Type Traditional
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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