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510(k) K922715

IMMUCHEM PRL-MW ELISA by Icn Biomedicals, Inc. — Product Code CFT

K922715 is an FDA 510(k) premarket notification submitted by Icn Biomedicals, Inc. for the device "IMMUCHEM PRL-MW ELISA". The FDA issued a decision of Substantially Equivalent on October 5, 1992. The device falls under product code CFT (Radioimmunoassay, Prolactin (Lactogen)), a Class I device regulated under 21 CFR 862.1625. Icn Biomedicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1992
Date Received
June 5, 1992
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 Icn Biomedicals, Inc.

  • K030211 — RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 (June 13, 2003)
  • K023252 — RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 (November 22, 2002)
  • K926106 — IMMUCHEM PHE-MW EA (February 8, 1995)
  • K922944 — IMMUCHEM LH-MW ELISA (February 2, 1993)
  • K922376 — ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT (October 5, 1992)
  • K920442 — IMMUCHEM TSH-MW ELISA (March 18, 1992)
  • K913963 — IMMUCHEM NEONATAL TSH-MP ELISA (December 13, 1991)
  • K902445 — LYMPHO SEP(TM) (August 22, 1990)
  • K885198 — 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA (February 23, 1989)
  • K881005 — IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG (May 27, 1988)

Other clearances for product code CFT

  • K971921 — PROLACTIN (PRL) HORMONE MICROPLATE ELISA (June 24, 1997)
  • K970281 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS (February 25, 1997)
  • 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)

FDA data resources