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510(k) K791202

RIA KIT FOR TRYPSIN by Cis Radiopharmaceuticals, Inc. — Product Code JNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1979
Date Received
June 28, 1979
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 Cis Radiopharmaceuticals, Inc.

  • K791860 — FERRITIN RIA KIT (December 6, 1979)
  • K792063 — FOLLICLE STIMULATING HORMONE (FSH) KIT (November 20, 1979)
  • K792000 — LUTEINIZING HORMONE (LH) RIA (October 30, 1979)
  • K791051 — PROGESTERONE RADIOIMMUNOASSAY KIT (July 24, 1979)
  • K790003 — RIA KIT, PROLACTIN (March 12, 1979)
  • K780982 — KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT (June 22, 1978)
  • K771878 — IRIDIUM 192 WIRES & PINS (October 27, 1977)
  • K760251 — SET, ORAL ADMINISTRATION (September 15, 1976)

Other clearances for product code JNO

  • K110274 — AUTODELFIA NEONATAL IRT KIT (June 10, 2011)
  • 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)