Grifols USA, LLC.

Los Angeles, CA, US

Grifols USA, LLC. appears in FDA device records in Los Angeles, CA. FDA records list 3 510(k) clearances between 2011-03-07 and 2012-12-14, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

FDA records hold 3 510(k) clearances for Grifols USA, LLC. between 2011 and 2012. The busiest year on record is 2012, with 2. The most recent is 2012, with 2.

Clearances by year, as a table

510(k) clearance decisions for Grifols USA, LLC., by decision year
Year	Clearances
2011	1
2012	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K113377	GLIADIN IGA AND GLIADIN LGA	MST	Substantially Equivalent	2012-12-14
K120169	INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT	CFF	Substantially Equivalent	2012-08-24
K102964	EU-TTG IGA AND EU-TTG IGG	MVM	Substantially Equivalent	2011-03-07

Registered establishments

FDA registered establishments for Grifols USA, LLC., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1066369	3003346238	Grifols USA, LLC.	2410 Grifols Way, Los Angeles, CA 90032 US	2026	No 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 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain