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Blaine Labs, Inc.

Santa Fe Springs, CA, US

BLAINE LABS, INC. appears in FDA device records in Santa Fe Springs, CA. FDA records list one 510(k) clearance, 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
1
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Blaine Labs, Inc. in 2000.

Clearances by year, as a table
510(k) clearance decisions for Blaine Labs, Inc., by decision year
YearClearances
20001
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K001608BLAINE SCARCARE PATCHMDASubstantially Equivalent

Registered establishments

FDA registered establishments for Blaine Labs, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30017441923001744192BLAINE LABS, INC.11037 LOCKPORT PLACE, SANTA FE SPRINGS, CA 90670 US2026

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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What MDM checks, and what it does not

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