Device Listing 2007765821

Listing Summary#

Listing key: 2007765821
Premarket submission: K042521
Device: VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS
Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: JIT
Decision date: 2004-11-18

Registration key, Registration, FEI table
Registration key	Registration	FEI	Company	Status	Initial importer	Expiration	Address
312290	1319681	1000136573	ORTHO-CLINICAL DIAGNOSTICS, INC.	1	N	2026-01-01	100 Indigo Creek Dr Rochester NY US 14626
312600	1319808	1000305841	ORTHO-CLINICAL DIAGNOSTICS, INC.	1	N	2026-01-01	1000 LEE RD. Rochester NY US 14606
312213	2250051	2250051	ORTHO-CLINICAL DIAGNOSTICS, INC.	1	N	2026-01-01	1001 US Highway 202 RARITAN NJ US 08869
312670	3000308930	3000308930	Ortho-Clinical Diagnostics European Support Center	1	N	2026-01-01	1500 Boulevard Sebastien Brant B.P. 30335 Illkirch, CEDEX Bas-Rhin FR 67411
312288	3002642396	3002642396	Ortho Clinical Diagnostics	1	N	2026-01-01	1 International Business Park, The Synergy #01-11/12 Singapore South West SG 609917
312609	3012963943	3012963943	Marlene Hanna	1	N	2026-01-01	100 Indigo Creek Dr Rochester NY US 14626