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510(k) K926106

IMMUCHEM PHE-MW EA by Icn Biomedicals, Inc. — Product Code JNB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1995
Date Received
December 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Device Class
Class II
Regulation Number
862.1555
Review Panel
CH
Submission Type

Other clearances by Icn Biomedicals, Inc.

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  • K922944 — IMMUCHEM LH-MW ELISA (February 2, 1993)
  • K922715 — IMMUCHEM PRL-MW ELISA (October 5, 1992)
  • 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 JNB

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  • K003584 — NEOLYNX SCREENING APPLICATION MANAGER (March 19, 2001)
  • K000754 — QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT (June 19, 2000)
  • K984463 — QUANTASE PHE/GAL SCREENING ASSAY (February 16, 1999)
  • K982307 — WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 (February 2, 1999)
  • K974047 — ACCUWELL PHENYLALANINE ASSAY (December 5, 1997)
  • K963040 — MANUAL PHENYLALANINE TEST (October 1, 1996)
  • K960437 — RADIAS PHENYLALANINE TEST (August 16, 1996)
  • K961515 — QUANTASE PHENYLALANINE ASSAY (June 12, 1996)
  • K943547 — PHENYLALANINE TEST KIT (January 26, 1996)