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510(k) K883011

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

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

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  • K843138 — CMV TEST (January 29, 1985)
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  • K803133 — RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL (January 29, 1981)
  • K803175 — RUBELLA VIRUS SEROLOGICAL REAGENTS (January 29, 1981)

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