PARA 12 PLUS

Control, Cell Counter, Normal And Abnormal

STRECK LABORATORIES, INC.

The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Para 12 Plus.

Pre-market Notification Details

Device IDK901875
510k NumberK901875
Device Name:PARA 12 PLUS
ClassificationControl, Cell Counter, Normal And Abnormal
Applicant STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha,  NE  68144
ContactHalvor Sornson
CorrespondentHalvor Sornson
STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha,  NE  68144
Product CodeJCN  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-26
Decision Date1990-05-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740017118 K901875 000
00380740017101 K901875 000
00844509000235 K901875 000
00844509000228 K901875 000
00844509000211 K901875 000
20844509000208 K901875 000
20844509000192 K901875 000
20844509000185 K901875 000
30844509000199 K901875 000

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