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510(k) K110274

AUTODELFIA NEONATAL IRT KIT by Wallac Oy, A Subsidiary of Perkinelmer, Inc. — Product Code JNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2011
Date Received
January 31, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
Device Class
Class I
Regulation Number
862.1725
Review Panel
CH
Submission Type

Other clearances by Wallac Oy, A Subsidiary of Perkinelmer, Inc.

  • K173829 — NeoLSD MSMS kit (July 18, 2018)
  • K133652 — GSP NEONATAL TOTAL GALACTOSE KIT (April 28, 2014)
  • K103484 — GSP NEONATAL THYROXINE (T4) (April 22, 2011)

Other clearances for product code JNO

  • K102419 — GSP NEONATAL IRT KIT (3306-001U) (December 16, 2010)
  • K932406 — NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT (December 2, 1993)
  • K883011 — MRI NEO-TRYP TRYPSIN RIA (April 26, 1989)
  • K861097 — TRYPSIN RIA KIT (May 29, 1986)
  • K811805 — TRYPIN (125I) RIA KIT (August 31, 1981)
  • K791202 — RIA KIT FOR TRYPSIN (November 5, 1979)