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510(k) K883011

MRI NEO-TRYP TRYPSIN RIA by Microbiological Research Corp. — Product Code JNO

K883011 is an FDA 510(k) premarket notification submitted by Microbiological Research Corp. for the device "MRI NEO-TRYP TRYPSIN RIA". The FDA issued a decision of Substantially Equivalent on April 26, 1989. 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. Microbiological Research Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1989
Date Received
July 19, 1988
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 Microbiological Research Corp.

  • K861120 — THE GOLDEN QUAD TEST (HSV) (February 2, 1987)
  • K861121 — THE GOLDEN QUAD TEST (EBV) (February 2, 1987)
  • K861122 — THE GOLDEN QUAD TEST (TOXO) (February 2, 1987)
  • K861123 — THE GOLDEN QUAD TEST (CMV) (February 2, 1987)
  • K860450 — THE CMV-IGM TEST (May 13, 1986)
  • K843138 — CMV TEST (January 29, 1985)
  • K821018 — ANTIHUMAN IGG GLOBULIN FITC LABELED (April 29, 1982)
  • K821019 — PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU (April 26, 1982)
  • K803175 — RUBELLA VIRUS SEROLOGICAL REAGENTS (January 29, 1981)
  • K803133 — RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL (January 29, 1981)

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)
  • K861097 — TRYPSIN RIA KIT (May 29, 1986)
  • K811805 — TRYPIN (125I) RIA KIT (August 31, 1981)
  • K791202 — RIA KIT FOR TRYPSIN (November 5, 1979)

FDA data resources