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510(k) K802038

PHENYTOIN REAGENT TEST KIT by Beckman Instruments, Inc. — Product Code DID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1980
Date Received
August 25, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bacillus Subtilis Microbiology Assay, Tobramycin
Device Class
Class II
Regulation Number
862.3900
Review Panel
TX
Submission Type

Other clearances by Beckman Instruments, Inc.

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  • K981403 — IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT (May 8, 1998)
  • K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 (May 1, 1998)
  • K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 (March 18, 1998)
  • K974816 — ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 (February 20, 1998)
  • K974564 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (February 17, 1998)
  • K974110 — IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT (December 24, 1997)
  • K974452 — VIGIL LIPID CONTROL (December 17, 1997)
  • K973932 — BECKMAN CALIBRATOR 2 (CAL2) (December 15, 1997)

Other clearances for product code DID

  • K820773 — EMIT-ST URINE COCAINE METABOLITE ASSAY (April 8, 1982)
  • K780950 — BIO-MONITOR TOBRAMYCIN (August 14, 1978)
  • K780182 — TOBRAMYCIN 125I RIA KIT (February 13, 1978)
  • K780048 — AMINOGLYCOSIDE TEST SYSTEM (January 20, 1978)