REAADS PROTEIN S ANTIGEN TEST KIT— 510(k) K972482

Clearance details

Applicant

Reaads Medical Products, Inc.

Product code

Code GGP

Device class

Class 2

Regulation

21 CFR 864.7290

Advisory panel

Hematology

Date received

1997-07-02

Decision date

1997-08-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Westminster, CO, US

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• Z-0106-2019 — "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Reference Plasma, 1x12 mL Protein S Conjugate Solution, 1 x 60mL Sample Diluent, 1 x 13mL Substrate, 1 x 15mL Stopping Solution, 1 x 30mL Phosphate Buffered Saline, 1 x 2mL Free Protein S Reagent FOR IN-VITRO DIAGNOSTIC USE LOT: 3-16- 5292 EXP: 2018-01-26 HELENA LABORATORIES BEAUMONT, TX Outer labeling of Substrate (brown bottle and cap): "Substrate 13 mL" FOR IN-VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES Beaumont, Tx "2161421 EXP: 2018-01-26" Outer Labeling of Protein S Conjugate bottle (clear bottle and cap, red liquid): "Protein S Conjugate 12 mL" FOR IN-VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES Beaumont, Tx "2161421 EXP: 2018-01-26"Class II·Terminated·Helena Laboratories, Inc.·20170404

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972482.