SPOROX TEST STRIPS— 510(k) K972035
Substantially EquivalentSerim Research Corp.
FDA 510(k) clearance K972035 for SPOROX TEST STRIPS, Substantially Equivalent on 1997-08-29. Applicant: Serim Research Corp.. Device class: 2.
Clearance details
- Applicant
- Serim Research Corp.
- Product code
- Code JOJ
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkhart, IN, US
Recent devices under product code JOJ
view all- K260181 — LF Process Indicator Tape for Steam Sterilization
- K251991 — SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016) +1 more
- K251035 — DISINTEK PA Test Strips
- K251048 — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
- K243876 — VERIFY STEAM Integrating Indicator
More clearances from Serim Research Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.