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510(k) K904458

LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION by London Diagnostics, Inc. — Product Code CFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1990
Date Received
October 1, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Prolactin (Lactogen)
Device Class
Class I
Regulation Number
862.1625
Review Panel
CH
Submission Type

Other clearances by London Diagnostics, Inc.

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  • K912858 — LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY (July 30, 1991)
  • K905814 — LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY (February 4, 1991)
  • K903130 — LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY (September 25, 1990)
  • K902443 — LUMATAG(TM) LH DIAGNOSTIC KIT (August 2, 1990)
  • K903195 — LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY (August 2, 1990)
  • K901484 — LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC (May 1, 1990)
  • K901075 — LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET. (April 2, 1990)
  • K881443 — LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY (May 27, 1988)

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  • K970188 — SEALITE SCIENCES, INC. AQUALITE PROLACTIN (February 20, 1997)
  • K964748 — ELECSYS PROLACTIN ASSAY (January 21, 1997)
  • K960561 — DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 (April 26, 1996)
  • K960060 — DSL ACTIVE PROLACTIN IRMA (February 29, 1996)
  • K954680 — ACCESS PROLACTIN ASSAY (MODIFICATION) (October 20, 1995)
  • K953656 — ABBOTT IMX PROLACTIN(MODIFICATION) (October 3, 1995)
  • K953657 — ABBOTT AXSYM PROLACTIN(MODIFICATION) (September 25, 1995)
  • K944698 — AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 (March 21, 1995)