3m Comply Bowie- Dick Type Lead Free Test Pack
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K093199 FDA 510(k)
- FDA Product Code
- JOJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2800 FDA 510(k)
- Regulation Number
- 880.2800 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an indicator, physical/chemical sterilization process test pack designed to evaluate the efficacy of steam sterilization cycles. It consists of a lead-free steam-sensitive chemical indicator test sheet positioned within a package of layered porous materials, equivalent in performance to the Bowie-Dick towel pack described in AAMI ST-79.
The test pack is supplied as a disposable, single-use device intended for use in general hospital settings to monitor steam sterilizer performance. It is not sterile, not MRI safety evaluated, and is regulated under FDA 510(k) clearance K093199 with device class 2 and product code JOJ.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF 3M Comply Bowie-Dick Type Test Pack 1233LF, 3M Comply Bowie-Dick Test Pack | 1233LF - Vitality Medical, 3M Bowie-Dick Tests for Medical | 3M United States, 3M Comply Bowie-Dick Test Pack Lead-Free - surgo.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093199 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K093199 24 fields · synced Sep 24, 2026