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FDA Product Code

FDA Product Code PPM — Clearance Directory

Device Class
Class I
Assigned Panel
Pathology
21 CFR Citation
864.4010

510(k) Clearances — 16 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K871533 TOMTEC GRAM STAINER DECOLORIZER Remel Co. 1987-04-29 Traditional PDF ↗
K863550 POTASSIUM HYDROXIDE 10% W/V Reagent Laboratory, Inc. 1986-10-02 Traditional PDF ↗
K861890 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 Richard-Allan Medical Ind., Inc. 1986-06-03 Traditional PDF ↗
K850916 SPRAYFIX Surgipath Medical Industries, Inc. 1985-03-25 Traditional PDF ↗
K850737 TRANSPORT CULTURE MEDIUM Roseville Medical Laboratoriesu 1985-03-20 Traditional PDF ↗
K850845 0.85% SALINE Micro Media Laboratories 1985-03-20 Traditional PDF ↗
K842934 DECOLORIZING FLUIC, ACID-ALCOHOL 3% E K Ind., Inc. 1984-09-12 Traditional PDF ↗
K842863 PRO-SOFT DEHYDRANT Anatech, Ltd. 1984-08-21 Traditional PDF ↗
K842729 DECOLORIZING FLUID E K Ind., Inc. 1984-08-03 Traditional PDF ↗
K842070 IDD DETERGENT Interscience Diagnostics, Inc. 1984-07-02 Traditional PDF ↗
K831620 SODIUM HYPOCHLORITE 3% Omega Medical Diagnostics 1983-07-28 Traditional PDF ↗
K831619 SODIUM HYPOCHLORITE 7% Omega Medical Diagnostics 1983-07-28 Traditional PDF ↗
K822326 BLENDED DETERGENT-78N 1912-1 Interscience, Inc. 1982-10-18 Traditional PDF ↗
K822037 VOLU-SOL TAP WATER SUBSTITUTE Volu Sol Medical Industries 1982-08-03 Traditional PDF ↗
K811800 BLUING REAGENT Richard-Allan Medical Ind., Inc. 1981-08-12 Traditional PDF ↗
K811796 FORMAL ALCOHOL Richard-Allan Medical Ind., Inc. 1981-07-28 Traditional PDF ↗

Product code PPM · Class I · Pathology. Data: openFDA.