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510(k) K950292

FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM by Miles, Inc. — Product Code CGN

K950292 is an FDA 510(k) premarket notification submitted by Miles, Inc. for the device "FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM". The FDA issued a decision of Substantially Equivalent on May 2, 1995. The device falls under product code CGN (Acid, Folic, Radioimmunoassay), a Class II device regulated under 21 CFR 862.1295. Miles, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1995
Date Received
January 25, 1995
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 Miles, Inc.

  • K950353 — TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (April 20, 1995)
  • K950186 — CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (March 13, 1995)
  • K945655 — CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC T (January 5, 1995)
  • K941171 — TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (December 14, 1994)
  • K943376 — OPERA SYSTEM (September 14, 1994)
  • K941156 — TECHNISON AXON SYSTEM (April 26, 1994)
  • K933682 — DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS (April 12, 1994)
  • K935287 — IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM (January 3, 1994)
  • K933478 — TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 (November 22, 1993)
  • K933475 — TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 (November 22, 1993)

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