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510(k) K761062

HISTO-TEK W/ AUTOMATIC COVERSLIPPER by Miles Laboratories, Inc. — Product Code IEO

K761062 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "HISTO-TEK W/ AUTOMATIC COVERSLIPPER". The FDA issued a decision of Substantially Equivalent on March 7, 1977. The device falls under product code IEO (Processor, Tissue, Automated), a Class I device regulated under 21 CFR 864.3875. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1977
Date Received
November 18, 1976
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

Other clearances by Miles Laboratories, Inc.

  • K880605 — LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER (May 26, 1988)
  • K874909 — MICRO-BUMINTEST REAGENT TABLETS (April 28, 1988)
  • K875079 — MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE (April 5, 1988)
  • K871835 — GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT (December 22, 1987)
  • K872120 — SERALYZER III BLOOD CHEMISTRY ANALYZER (October 28, 1987)
  • K873304 — CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (September 11, 1987)
  • K872634 — CUTTER PUREFLO PLUS IV FILTER (August 4, 1987)
  • K870214 — MODIFIED SALTEX REAGENT STRIPS (June 29, 1987)
  • K870752 — SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS (April 14, 1987)
  • K865053 — SERA-TEK MICROSOMAL ANTIBODY TEST (February 18, 1987)

Other clearances for product code IEO

  • K924590 — MICROWAVE AUTOMATED TISSUE PROCESSOR (December 29, 1992)
  • K883599 — LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) (September 2, 1988)
  • K881165 — SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR (July 1, 1988)
  • K853938 — LX 300 TISSUE PROCESSOR (October 10, 1985)
  • K851054 — LX120 TISSUE PROCESSOR (May 15, 1985)
  • K843506 — LKB 2189 ULTROPROCESSOR (November 30, 1984)
  • K834599 — AUTOTECHNICON V TISSUE PROCESS SYS (February 4, 1984)
  • K831313 — TISSUE-TEK V.I.P. 100/200 (July 28, 1983)
  • K801513 — TISSUE PROCESSING SYSTEM (July 28, 1980)
  • K801427 — TISSUE-TEK III MINI-RAPID PROCESSOR (July 28, 1980)

FDA data resources