X-ACT LDC/IND

Culture Media, Multiple Biochemical Test

PRO-LAB, INC.

The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for X-act Ldc/ind.

Pre-market Notification Details

Device IDK883996
510k NumberK883996
Device Name:X-ACT LDC/IND
ClassificationCulture Media, Multiple Biochemical Test
Applicant PRO-LAB, INC. 290 LARKIN ST. P.O. BOX 1099 Buffalo,  NY  14210
ContactKay Baitz
CorrespondentKay Baitz
PRO-LAB, INC. 290 LARKIN ST. P.O. BOX 1099 Buffalo,  NY  14210
Product CodeJSE  
CFR Regulation Number866.2320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-20
Decision Date1988-10-12

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