Cleared Traditional

HEMOCARD CONTROL HB-AA, AE, FAA, FAE

K931234 · Isolab, Inc. · Chemistry
May 1993
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K931234 is an FDA 510(k) clearance for the HEMOCARD CONTROL HB-AA, AE, FAA, FAE, a Control, Hemoglobin, Abnormal (Class II — Special Controls, product code JCM), submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on May 11, 1993, 62 days after receiving the submission on March 10, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number K931234 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1993
Decision Date May 11, 1993
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JCM — Control, Hemoglobin, Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7415

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