MODIFICATION OF: STERRAD BI TEST PACK— 510(k) K991675
Substantially EquivalentAdvanced Sterilization Products
FDA 510(k) clearance K991675 for MODIFICATION OF: STERRAD BI TEST PACK, Substantially Equivalent on 1999-06-15. Applicant: Advanced Sterilization Products. Device class: 2.
Clearance details
- Applicant
- Advanced Sterilization Products
- Product code
- Code FRC
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvin, CA, US
Recent devices under product code FRC
view allMore clearances from Advanced Sterilization Products
view all- K234082 — STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104) +1 more
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- K162007 — STERRAD NX Sterilizer
- K160818 — STERRAD® NX Sterilizer with ALLClear Technology
- K160903 — STERRAD 100NX Sterilizer with ALLClearTM Technology
Data sourced from openFDA. This site is unofficial and independent of the FDA.