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510(k) K802628

PARAGON ELECTROPHORESIS LACTATE REAG.KIT by Beckman Instruments, Inc. — Product Code CFE

K802628 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "PARAGON ELECTROPHORESIS LACTATE REAG.KIT". The FDA issued a decision of Substantially Equivalent on December 11, 1980. The device falls under product code CFE (Electrophoretic, Lactate Dehydrogenase Isoenzymes), a Class II device regulated under 21 CFR 862.1445. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1980
Date Received
October 23, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic, Lactate Dehydrogenase Isoenzymes
Device Class
Class II
Regulation Number
862.1445
Review Panel
CH
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 CFE

  • K100307 — GELSCAN, MODEL 1206 (August 31, 2010)
  • K022455 — SPIFE LD-12 KIT, MODEL 3338 (October 1, 2002)
  • K020467 — SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 (March 29, 2002)
  • K970477 — HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT (March 10, 1997)
  • K940224 — CARDIO REP LD (August 17, 1994)
  • K921455 — ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD (April 29, 1992)
  • K905861 — ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH (February 6, 1991)
  • K894081 — ROCHO ISOMUNE - LD (August 31, 1989)
  • K892818 — REP(TM) LD-2 STAT KIT, CAT. NO. 3078 (June 20, 1989)
  • K874142 — TITAN GEL REP LDH-30 HV (November 24, 1987)

FDA data resources