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510(k) K952568

BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT by Beckman Instruments, Inc. — Product Code LCR

K952568 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT". The FDA issued a decision of Substantially Equivalent on Aug 8, 1995. The device falls under product code LCR (Fluorescent Immunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. Beckman Instruments, Inc. has 280 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 8, 1995
Date Received
Jun 5, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Fluorescent Immunoassay, Tobramycin
Device Class
Class II
Regulation Number
862.3900
Review Panel
TX
Submission Type
510(k)

Other clearances by Beckman Instruments, Inc.

  • K973448 — ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460… (Sep 17, 1998)
  • K982250 — ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (Jul 14, 1998)
  • 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 (Mar 18, 1998)
  • K974816 — ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 (Feb 20, 1998)
  • K974564 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (Feb 17, 1998)
  • K974110 — IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT (Dec 24, 1997)
  • K974452 — VIGIL LIPID CONTROL (Dec 17, 1997)
  • K973932 — BECKMAN CALIBRATOR 2 (CAL2) (Dec 15, 1997)

Other clearances for product code LCR

  • K060998 — QMS TOBRAMYCIN (Jul 21, 2006)
  • K974029 — ACS TOBRAMYCIN (Feb 12, 1998)
  • K962818 — TOBRAMYCIN FLEX REAGENT CARTRIDGE (Sep 13, 1996)
  • K911940 — OPUS(R) TOBRAMYCIN (Jul 1, 1991)
  • K911613 — VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 (Jun 28, 1991)
  • K854873 — INTRAOCULAR PRESSURE REDUCER (Feb 4, 1986)
  • K850058 — DU PONT TOBRAMYCIN ASSAY REAGENTS (Jan 18, 1985)
  • K840847 — IMMPULSE TOBRAMYCIN ASSAY REAGENTS (Apr 4, 1984)
  • K832408 — STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM (Aug 26, 1983)
  • K822197 — NEEDLE HOLDERS (Aug 16, 1982)

FDA data resources

Source: FDA 510(k) database entry for K952568. Report a data issue: hello@regdatalab.com.