NATAL CALF (BOVINE) SERUM - STERILE

Sera, Animal And Human

DUTCHLAND LABORATORIES, INC.

The following data is part of a premarket notification filed by Dutchland Laboratories, Inc. with the FDA for Natal Calf (bovine) Serum - Sterile.

Pre-market Notification Details

Device IDK812385
510k NumberK812385
Device Name:NATAL CALF (BOVINE) SERUM - STERILE
ClassificationSera, Animal And Human
Applicant DUTCHLAND LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKIS  
CFR Regulation Number864.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-08-20
Decision Date1981-09-08

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