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510(k) K861097

TRYPSIN RIA KIT by Microanalytic Research, Inc. — Product Code JNO

K861097 is an FDA 510(k) premarket notification submitted by Microanalytic Research, Inc. for the device "TRYPSIN RIA KIT". The FDA issued a decision of Substantially Equivalent on May 29, 1986. The device falls under product code JNO (N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin), a Class I device regulated under 21 CFR 862.1725. Microanalytic Research, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1986
Date Received
March 24, 1986
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 Microanalytic Research, Inc.

  • K820741 — MR1 LUTROPIN RIA KIT (April 14, 1982)
  • K820740 — MR1 FOLLITROPIN RIA KIT (April 6, 1982)
  • K813516 — MRI TOBRAMYCIN RIA KIT (December 29, 1981)
  • K812394 — MRI GENTAMICIN RIA KIT (September 8, 1981)
  • K810949 — MRI PROLACTIN RIA KIT (July 10, 1981)
  • K802754 — IMMUNOREACTIVE ESTRIOL RIA KIT (January 21, 1981)
  • K801491 — MRI HCG-BETA RIA KIT CAT. #MR-10100 (August 13, 1980)

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)
  • K811805 — TRYPIN (125I) RIA KIT (August 31, 1981)
  • K791202 — RIA KIT FOR TRYPSIN (November 5, 1979)

FDA data resources