Cleared Traditional

FETAL CHECK

K792546 · Alta Diagnostics, Inc. · Pathology
Dec 1979
Decision
8d
Days
Class 1
Risk

About This 510(k) Submission

K792546 is an FDA 510(k) clearance for the FETAL CHECK, a Erythrosin B (Class I — General Controls, product code KJR), submitted by Alta Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 18, 1979, 8 days after receiving the submission on December 10, 1979. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K792546 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 1979
Decision Date December 18, 1979
Days to Decision 8 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KJR — Erythrosin B
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850