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510(k) K760161

TEST, ACID PHOSPHATASE by Princeton Biomedix — Product Code CJR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1976
Date Received
July 2, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid Phosphatase, Thymol Blue Monophosphate
Device Class
Class II
Regulation Number
862.1020
Review Panel
CH
Submission Type

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  • K892654 — BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST (June 19, 1989)
  • K761315 — ALKALINE PHOSPHATASE (ALP)/PNPP (February 24, 1977)

Other clearances for product code CJR

  • K842516 — SANDARE ACID PHOSPHATASE PROCEDURE (August 17, 1984)