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510(k) K760278

SLIDE, LAB-TEK COVERED MICRO by Miles Laboratories, Inc. — Product Code KEW

K760278 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "SLIDE, LAB-TEK COVERED MICRO". The FDA issued a decision of Substantially Equivalent on August 30, 1976. The device falls under product code KEW (Slides, Microscope), a Class I device regulated under 21 CFR 864.3010. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1976
Date Received
July 23, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Slides, Microscope
Device Class
Class I
Regulation Number
864.3010
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 KEW

  • K891604 — THE CEN-SLIDE(TM) CENTRIFUGE TUBE (June 16, 1989)
  • K890042 — MICROSCOPE SLIDES PRECOATED (January 13, 1989)
  • K882357 — MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY (June 16, 1988)
  • K831065 — SECTIONING AID KIT (June 8, 1983)
  • K820100 — FROSTED GLASS SLIDES (March 4, 1982)
  • K813242 — QUANTIMETRIC 2 TEST KIT (December 2, 1981)
  • K800232 — ABCO ULTRA SLIDE MICROSCOPE SLIDE (February 21, 1980)

FDA data resources