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510(k) K964756

PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT by Wano-Tech Corp. — Product Code JFH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1997
Date Received
November 27, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid Phosphatase (Prostatic), Tartrate Inhibited
Device Class
Class II
Regulation Number
862.1020
Review Panel
CH
Submission Type

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  • K895723 — IRMA-COUNT(TM) PAP, (RKPA1, RKPA2) (October 31, 1989)
  • K893508 — PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI (August 4, 1989)
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