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510(k) K950353

TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM by Miles, Inc. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1995
Date Received
January 30, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

Other clearances by Miles, Inc.

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  • 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)
  • K933475 — TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 (November 22, 1993)
  • K933478 — TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 (November 22, 1993)

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