PROSPORE— 510(k) K971432
Substantially EquivalentRaven Biological Laboratories, Inc.
FDA 510(k) clearance K971432 for PROSPORE, Substantially Equivalent on 1997-05-20. Applicant: Raven Biological Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Raven Biological Laboratories, Inc.
- 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
- Traditional
- Location
- Omaha, NE, US
Recent devices under product code FRC
view allMore clearances from Raven Biological Laboratories, Inc.
view allRecalls naming K971432
K-number listed on FDA's recall record- Z-1273-2018 — ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
- Z-1274-2018 — SporAmpule Biological Indicator Catalog Number SPS5-100
- Z-1104-2017 — ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K971432.
Data sourced from openFDA. This site is unofficial and independent of the FDA.