HUMAN SERUM ALBUMIN (HSA)

Media, Reproductive

INVITROCARE, INC.

The following data is part of a premarket notification filed by Invitrocare, Inc. with the FDA for Human Serum Albumin (hsa).

Pre-market Notification Details

Device IDK000940
510k NumberK000940
Device Name:HUMAN SERUM ALBUMIN (HSA)
ClassificationMedia, Reproductive
Applicant INVITROCARE, INC. 11408 SORRENTO VALLEY RD. SUITE 202 San Diego,  CA  92121
ContactRobert E Lovins
CorrespondentRobert E Lovins
INVITROCARE, INC. 11408 SORRENTO VALLEY RD. SUITE 202 San Diego,  CA  92121
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-23
Decision Date2000-05-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00859268006114 K000940 000

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