BECKMAN COULTER Lipoprotein(a)Calibrator

Beckman Coulter,Inc.

國食藥監(jiān)械(進(jìn))字2012第2404011號(hào)(變更批件)

250 South Kraemer Blvd., Brea, CA 92821, USA

2012-11-19

2016-11-18

美國

變更內(nèi)容:生產(chǎn)企業(yè)注冊(cè)地址由4300 N.HarborBlvd.,Fullerton,CA 92834-3100,USA變更為250 SouthKraemer Blvd., Brea, CA 92821, USA,生產(chǎn)企業(yè)生產(chǎn)地址由2470 Faraday Ave.,Carlsbad CA92008-7224,USA變更為為2470 Faraday AvenueCarlsbad, CA 92010,USA申請(qǐng)人根據(jù)批準(zhǔn)變更內(nèi)容自行修訂注冊(cè)產(chǎn)品標(biāo)準(zhǔn)、說明書及包裝標(biāo)簽中相應(yīng)內(nèi)容。審批結(jié)論:根據(jù)《體外診斷試劑注

YZB/USA 4806-2012

2470 Faraday Avenue Carlsbad, CA 92010, USA

2×1mL