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510(k) K801426

TISSUE-TEK III MICROJECT DISP. BLADE SYS by Miles Laboratories, Inc. — Product Code IDL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1980
Date Received
June 17, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microtome, Accessories
Device Class
Class I
Regulation Number
864.3010
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)

Other clearances for product code IDL

  • K863616 — KNIFE MAKER (September 25, 1986)
  • K831921 — DISPOSABLE MICROTOME BLADES (July 29, 1983)
  • K831308 — DISPOSABLE MICROTOME BLADE (May 16, 1983)
  • K813430 — TISSUE PROCESSING CASSETTES & ACCESS (December 29, 1981)