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510(k) K860924

RAMP PROGESTURINE PDG ASSAY--48 TEST KIT by Monoclonal Antibodies, Inc. — Product Code JLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1986
Date Received
March 11, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Progesterone
Device Class
Class I
Regulation Number
862.1620
Review Panel
CH
Submission Type

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  • K850480 — OVU STICK SELF-TEST -MODIFICATION (March 5, 1985)
  • K843284 — OVUSTICK SELF-TEST (December 11, 1984)
  • K840738 — PLUS URINE HCG ASSAY (April 19, 1984)
  • K840412 — OVU STICK URINE HLH KIT (April 13, 1984)
  • K833504 — PREGNASTICK URINE HCG KIT (January 9, 1984)

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  • K952075 — PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM (June 13, 1995)
  • K951630 — AURAFLEX PROGESTERONE 150TEST PACK (May 8, 1995)