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510(k) K943691

IMX FOLATE by Abbott Mfg., Inc. — Product Code CGN

K943691 is an FDA 510(k) premarket notification submitted by Abbott Mfg., Inc. for the device "IMX FOLATE". The FDA issued a decision of Substantially Equivalent on March 23, 1995. The device falls under product code CGN (Acid, Folic, Radioimmunoassay), a Class II device regulated under 21 CFR 862.1295. Abbott Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1995
Date Received
July 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Folic, Radioimmunoassay
Device Class
Class II
Regulation Number
862.1295
Review Panel
CH
Submission Type

Other clearances by Abbott Mfg., Inc.

  • K981457 — ALBP (May 27, 1998)
  • K981232 — CA (May 18, 1998)
  • K981231 — CO2 (May 12, 1998)
  • K965230 — ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP (July 3, 1997)
  • K971293 — LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE (June 27, 1997)
  • K953656 — ABBOTT IMX PROLACTIN(MODIFICATION) (October 3, 1995)
  • K953657 — ABBOTT AXSYM PROLACTIN(MODIFICATION) (September 25, 1995)
  • K944669 — FLEXIFLO QUANTUM ENTERAL PUMP (July 24, 1995)
  • K943733 — FLEXIFLO SIX ENTERAL NUTRITION PUMP (December 12, 1994)
  • K941214 — LIFESHIELD EXTENSION SET (October 3, 1994)

Other clearances for product code CGN

  • K233060 — Elecsys Folate III (June 17, 2024)
  • K223590 — Access Folate Assay (August 23, 2023)
  • K192586 — LIAISON® Folate (May 6, 2020)
  • K172201 — Atellica IM Folate Assay (April 12, 2018)
  • K161646 — Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set (November 4, 2016)
  • K141426 — ELECSYS FOLATE III (October 17, 2014)
  • K103716 — ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET (May 12, 2011)
  • K092740 — ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CO (March 5, 2010)
  • K091332 — AIA-PACK RBC FOLATE (October 2, 2009)
  • K082340 — ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELE (June 19, 2009)

FDA data resources