Home / 510(k) Clearances / K782125

510(k) K782125

RIA KIT, KANAMYCIN by Diagnostic Products Corp. — Product Code KJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1979
Date Received
December 27, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Kanamycin
Device Class
Class II
Regulation Number
862.3520
Review Panel
TX
Submission Type

Other clearances by Diagnostic Products Corp.

  • K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (December 5, 2006)
  • K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (January 21, 2004)
  • K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (December 12, 2003)
  • K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (October 10, 2003)
  • K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE (December 17, 2002)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE (December 9, 2002)
  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (August 21, 2002)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (July 22, 2002)
  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

Other clearances for product code KJI

  • K832769 — AMES TDA KANAMYCIN TEST-CONTROL SERUM (September 29, 1983)
  • K823370 — ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY (December 3, 1982)
  • K823062 — KENAMYCIN FLUORESCENT IMMUNOASSAY FIA (November 10, 1982)
  • K822808 — TDX KENAMYCIN (October 8, 1982)
  • K772038 — KANAMYCIN RIA (January 12, 1978)