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FDA Product Code

FDA Product Code ICL — Clearance Directory

Device Class
Class I
Assigned Panel
Hematology
21 CFR Citation
864.1850

510(k) Clearances — 4 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K890148 ATS TB RAPID STAIN SET PRODUCT #034-45 Alpha-Tec Systems, Inc. 1989-01-24 Traditional PDF ↗
K842933 CARBOL-FUCHSIN, ZIEHL-NEEDSEN E K Ind., Inc. 1984-09-11 Traditional PDF ↗
K792483 STAINS, COUNTERSTAINS & GEN. PURPOSE Laboratory Products, Inc. 1979-12-18 Traditional PDF ↗
K771390 HISTOCHEMICAL AFB DEMONSTRATION Harleco 1977-08-22 Traditional PDF ↗

Product code ICL · Class I · Hematology. Data: openFDA.