COLLAGEN REAGENT CAT. NO. 5368— 510(k) K910706

Clearance details

Applicant

Helena Laboratories

Product code

Code GHR

Device class

Class 2

Regulation

21 CFR 864.5700

Advisory panel

Hematology

Date received

1991-02-20

Decision date

1991-05-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Beaumont, TX, US

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• Z-0536-2020 — Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3)Class III·Ongoing·Helena Laboratories, Corp.·20180523
• Z-0537-2020 — Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,Class III·Ongoing·Helena Laboratories, Corp.·20180523

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K910706.