Cleared Traditional

K973100 - PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR
(FDA 510(k) Clearance)

K973100 · Dade Chemistry Systems, Inc. · Immunology

Sep 1997

Decision

41d

Days

Class 2

Risk

K973100 is an FDA 510(k) clearance for the PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Dade Chemistry Systems, Inc. (Newark, US). The FDA issued a Cleared decision on September 29, 1997, 41 days after receiving the submission on August 19, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number	K973100 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 1997
Decision Date	September 29, 1997
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF