LIQUI-SERA SPINAL FLUID CONTROL

Multi-analyte Controls, All Kinds (assayed)

BIO DIAGNOSTIC INTL.

The following data is part of a premarket notification filed by Bio Diagnostic Intl. with the FDA for Liqui-sera Spinal Fluid Control.

Pre-market Notification Details

Device IDK874459
510k NumberK874459
Device Name:LIQUI-SERA SPINAL FLUID CONTROL
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant BIO DIAGNOSTIC INTL. 1251 - Q SOUTH BEACH BLVD. La Habra,  CA  90631
ContactAnand, Phd
CorrespondentAnand, Phd
BIO DIAGNOSTIC INTL. 1251 - Q SOUTH BEACH BLVD. La Habra,  CA  90631
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-29
Decision Date1987-12-29

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