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510(k) K831313

TISSUE-TEK V.I.P. 100/200 by Miles Laboratories, Inc. — Product Code IEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1983
Date Received
April 22, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Tissue, Automated
Device Class
Class I
Regulation Number
864.3875
Review Panel
PA
Submission Type

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  • K870214 — MODIFIED SALTEX REAGENT STRIPS (June 29, 1987)
  • K870752 — SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS (April 14, 1987)
  • K864530 — SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. (February 18, 1987)

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  • K843506 — LKB 2189 ULTROPROCESSOR (November 30, 1984)
  • K834599 — AUTOTECHNICON V TISSUE PROCESS SYS (February 4, 1984)
  • K801513 — TISSUE PROCESSING SYSTEM (July 28, 1980)
  • K801427 — TISSUE-TEK III MINI-RAPID PROCESSOR (July 28, 1980)
  • K771308 — TISSUE-TEK III V.I.P. (August 22, 1977)