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510(k) K974816

ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 by Beckman Instruments, Inc. — Product Code LTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1998
Date Received
December 23, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

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  • K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 (May 1, 1998)
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  • K974564 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (February 17, 1998)
  • K974110 — IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT (December 24, 1997)
  • K974452 — VIGIL LIPID CONTROL (December 17, 1997)
  • K973932 — BECKMAN CALIBRATOR 2 (CAL2) (December 15, 1997)
  • K973928 — BECKMAN URINE PROTEIN CALIBRATOR (UCAL) (December 1, 1997)

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