PARA 12 PLUS RETICS

Mixture, Control, White-cell And Red-cell Indices

STRECK LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK000945
510k NumberK000945
Device Name:PARA 12 PLUS RETICS
ClassificationMixture, Control, White-cell And Red-cell Indices
Applicant STRECK LABORATORIES, INC. 14124 INDUSTRIAL RD. Omaha,  NE  68145 -0625
ContactPaul Kittelson
CorrespondentPaul Kittelson
STRECK LABORATORIES, INC. 14124 INDUSTRIAL RD. Omaha,  NE  68145 -0625
Product CodeGLQ  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-23
Decision Date2000-04-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740017095 K000945 000
00380740017088 K000945 000
00380740151287 K000945 000
00380740151270 K000945 000

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