Cleared Traditional

ASSERACHROM TPA TEST KIT

K971519 · American Bioproducts Co. · Hematology
Aug 1997
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K971519 is an FDA 510(k) clearance for the ASSERACHROM TPA TEST KIT, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on August 19, 1997, 116 days after receiving the submission on April 25, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K971519 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1997
Decision Date August 19, 1997
Days to Decision 116 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGP — Test, Qualitative And Quantitative Factor Deficiency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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