PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED

Media, Reproductive

SAGE BIOPHARMA

The following data is part of a premarket notification filed by Sage Biopharma with the FDA for Phosphate Buffered Saline (pbs), Phosphate Buffered Saline With Calcium, Magnesium, Glucose, Pyruvate And Phenol Red.

Pre-market Notification Details

Device IDK991378
510k NumberK991378
Device Name:PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED
ClassificationMedia, Reproductive
Applicant SAGE BIOPHARMA 3722 AVE. SAUSALITO Irvine,  CA  92606
ContactGreg Holland
CorrespondentGreg Holland
SAGE BIOPHARMA 3722 AVE. SAUSALITO Irvine,  CA  92606
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-21
Decision Date1999-09-24

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