510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031114Substantially Equivalent

Pro-Pact Peracetic Acid Culture Test Kit, Model C-3Pa

Raven Biological Laboratories, Inc., Omaha NE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K031114 is the FDA 510(k) clearance record for PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA, a class II device, cleared for Raven Biological Laboratories, Inc. on under FDA product code MRB (Indicator, Biological, Liquid Chemical Sterilization Process). FDA records list 15 510(k) clearances for Raven Biological Laboratories, Inc., from to . As of , FDA records show no recalls naming K031114.

Clearance record

Decision date
Received
(330 days to decision)
Product code
MRB Indicator, Biological, Liquid Chemical Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Raven Biological Laboratories, Inc. 8607 Park Dr., Omaha NE
510(k) summary
Statement
Third party review
No

Clearances, product code MRB

Trailing 12 months

FDA records hold no clearances under product code MRB in the trailing twelve months.

FDA records show no clearances under product code MRB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MRB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260