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510(k) K102419

GSP NEONATAL IRT KIT (3306-001U) by Wallac Oy, Subsidiary of Perkinelmer — Product Code JNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2010
Date Received
August 25, 2010
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

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  • 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)