PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR— 510(k) K973100

Substantially Equivalent

Dade Chemistry Systems, Inc.

FDA 510(k) clearance K973100 for PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR, Substantially Equivalent on 1997-09-29. Applicant: Dade Chemistry Systems, Inc..

Clearance details

Applicant: Dade Chemistry Systems, Inc.
Product code: Code JIT
Advisory panel: Clinical Chemistry
Date received: 1997-08-19
Decision date: 1997-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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