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510(k) K812394

MRI GENTAMICIN RIA KIT by Microanalytic Research, Inc. — Product Code DJB

K812394 is an FDA 510(k) premarket notification submitted by Microanalytic Research, Inc. for the device "MRI GENTAMICIN RIA KIT". The FDA issued a decision of Substantially Equivalent on September 8, 1981. The device falls under product code DJB (Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.), a Class II device regulated under 21 CFR 862.3450. Microanalytic Research, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1981
Date Received
August 20, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
Device Class
Class II
Regulation Number
862.3450
Review Panel
TX
Submission Type

Other clearances by Microanalytic Research, Inc.

  • K861097 — TRYPSIN RIA KIT (May 29, 1986)
  • K820741 — MR1 LUTROPIN RIA KIT (April 14, 1982)
  • K820740 — MR1 FOLLITROPIN RIA KIT (April 6, 1982)
  • K813516 — MRI TOBRAMYCIN RIA KIT (December 29, 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 DJB

  • K832792 — AMES TDA SISOMICIN TEST-CONTROL SERUM (September 29, 1983)
  • K831210 — GENTAMICIN TEST PACK-ACA (May 25, 1983)
  • K821669 — AMES TDA GENTAMICIN TEST (December 15, 1982)
  • K811844 — COAT-A-COUNT GENTAMICIN RIA KIT (July 10, 1981)
  • K800537 — GAMMA STICK GENTAMICIN RIA KIT (April 24, 1980)
  • K791770 — QUANTIMUNE GENTAMICIN RIA GENTAMICIN (October 17, 1979)
  • K791547 — FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY (October 12, 1979)
  • K782049 — BIOASSAY SYSTEM, MS-2 SERUM (August 28, 1979)
  • K790584 — AMES TDA/GENTGMICIN (June 15, 1979)
  • K790829 — EMIT GENTAMICIN ASSAY (May 15, 1979)

FDA data resources