Cleared Traditional

CAL-RITE

K811801 · Richard-Allan Medical Ind., Inc. · Hematology
Jul 1981
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K811801 is an FDA 510(k) clearance for the CAL-RITE, a Solution, Decalcifier, Acid Containing (Class I — General Controls, product code KDX), submitted by Richard-Allan Medical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1981, 34 days after receiving the submission on June 24, 1981. This device falls under the Hematology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K811801 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 1981
Decision Date July 28, 1981
Days to Decision 34 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KDX — Solution, Decalcifier, Acid Containing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010