Cleared Traditional

CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50

K023990 · Precision Biologic · Hematology
Mar 2003
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K023990 is an FDA 510(k) clearance for the CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Precision Biologic (Dartmouth, N.S., CA). The FDA issued a Cleared decision on March 19, 2003, 106 days after receiving the submission on December 3, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K023990 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2002
Decision Date March 19, 2003
Days to Decision 106 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGP — Test, Qualitative And Quantitative Factor Deficiency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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