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

Elgin, IL, US

HYDROX LABORATORIES, INC. appears in FDA device records in Elgin, IL. FDA records list 2 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show no recalls 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
0
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Hydrox Laboratories, Inc. in 1998.

Clearances by year, as a table
510(k) clearance decisions for Hydrox Laboratories, Inc., by decision year
YearClearances
19982
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K974759HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLEJOLSubstantially Equivalent
K974758HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLEJOLSubstantially Equivalent

Registered establishments

FDA registered establishments for Hydrox Laboratories, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30039417703003941770HYDROX LABORATORIES, INC.825 Tollgate Rd, Elgin, IL 60123 US2026No device listings on this registration

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

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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