BOWIE-DICK TEST CARD CATALOG NUMBER 008018— 510(k) K897045

Clearance details

Applicant

Edward Weck, Inc.

Product code

Code JOJ

Device class

Class 2

Regulation

21 CFR 880.2800

Advisory panel

General Hospital

Date received

1989-12-19

Decision date

1990-02-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Research Triangle Pa, NC, US

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• Z-2417-2012 — Verify¿ Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. On the opposite side of the card, space is provided for critical cycle information to be recorded. The card is laminated inside a thin clear plastic enclosure. The enclosure has two holes in it to allow air removal and steam penetration. The preassembled test is used to evaluate the effectiveness of air removal from the sterilizer chamber during prevacuum pulse steam sterilizer cycle. Following a prevacuum cycle, the chemical bars of the Bowie-Dick Test card uniformly darken indicating that residual air has been sufficiently removed to allow complete steam penetration into the test card. If air is trapped in the card during the exposure phase of the cycle, the color change of the bars will be incomplete or uneven. Thus the card can provide an immediate indication of inadequate removal of air during a cycle. The Bowie-Dick Type test is performed in an empty chamber each day the sterilizer is to be used, usually before the first sterilization cycle.Class II·Terminated·Steris Corporation·20120703

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K897045.