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510(k) K852117

CYTO-TEK CENTRIFUGE by Miles Laboratories, Inc. — Product Code IFB

K852117 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "CYTO-TEK CENTRIFUGE". The FDA issued a decision of Substantially Equivalent on June 10, 1985. The device falls under product code IFB (Cytocentrifuge), a Class I device regulated under 21 CFR 864.3300. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1985
Date Received
May 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cytocentrifuge
Device Class
Class I
Regulation Number
864.3300
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)
  • K864530 — SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. (February 18, 1987)

Other clearances for product code IFB

  • K810848 — CYTOBUCKET MODEL 1024 (April 23, 1981)
  • K792032 — LEIF CENTRIFUGAL CYTOLOGY BUCKET (November 30, 1979)

FDA data resources