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510(k) K800524

SERALYZER REFLECTANCE PHOTOMETER/CALIB. by Miles Laboratories, Inc. — Product Code CIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1980
Date Received
March 6, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Volumetric/Manometric, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

Other clearances by Miles Laboratories, Inc.

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  • 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 CIE

  • K904761 — P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT (November 20, 1990)
  • K880967 — MICRO CO2 APPARATUS (April 28, 1988)
  • K864313 — CO2 REAGENT SET (March 13, 1987)
  • K832071 — TOTAL CO2 REAGENT SET (August 11, 1983)
  • K820091 — AIRMED SMOKE EVACUATION & FILTER (February 24, 1982)
  • K771610 — CARBON DIOXIDE ANALYZER (October 7, 1977)