510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Best Sanitizers, Inc.

Walton, KY, US

Best Sanitizers, Inc. appears in FDA device records in Walton, KY. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Best Sanitizers, Inc. between 2005 and 2010. The busiest year on record is 2005, with 1. The most recent is 2010, with 1.

Clearances by year, as a table
510(k) clearance decisions for Best Sanitizers, Inc., by decision year
YearClearances
20051
20101
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K091210ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANTMEDSubstantially Equivalent
K041984ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANTMEDSubstantially Equivalent

Registered establishments

FDA registered establishments for Best Sanitizers, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30057634253005763425Best Sanitizers, Inc.154 Mullen Dr, Walton, KY 41094 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2714-2016Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of two liquids (1 acid & 1 buffer) banded together.Certain lots of the acid solution in Acecide-C are degrading faster than normal.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain