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510(k) K971210

SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS by Beckman Instruments, Inc. — Product Code LAS

K971210 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS". The FDA issued a decision of Substantially Equivalent on April 17, 1997. The device falls under product code LAS (Drug Specific Control Materials), a Class I device regulated under 21 CFR 862.3280. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1997
Date Received
April 2, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Specific Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

Other clearances by Beckman Instruments, Inc.

  • K973448 — ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, (September 17, 1998)
  • K982250 — ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (July 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 (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 LAS

  • K080459 — CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS (November 17, 2009)
  • K072257 — MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL (January 30, 2008)
  • K062942 — QUANTIMETRIX NICOSURE COTININE URINE CONTROL (October 30, 2006)
  • K051074 — MAS IMMUNOSUPPRESSANT CONTROLS (June 6, 2005)
  • K040411 — DRI OXYCODONE ASSAY (May 27, 2004)
  • K032842 — MICROGENICS CYCLOSPORINE CONTROL KIT (October 17, 2003)
  • K030616 — CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 (March 31, 2003)
  • K992151 — REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE (July 14, 1999)
  • K970517 — INNOFLUOR TOPIRAMATE CONTROL SET (May 12, 1997)
  • K946119 — ROCHE-TDM ONLEIN(TM) CONTROLS (February 7, 1995)

FDA data resources