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510(k) K801269

SERALYZER BLOOD UREA NITROGEN(BUN) by Miles Laboratories, Inc. — Product Code JGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1980
Date Received
May 28, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
O-Phthalaldehyde, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
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 JGZ

  • K904049 — ROCHE COBAS READY RENAL PROFILE REAGENT STRIP (October 12, 1990)
  • K896236 — COBAS READY BUN REAGENT (February 27, 1990)
  • K883327 — CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST (January 23, 1989)
  • K863901 — IQ UREA NITROGEN (November 24, 1986)
  • K842772 — PHARMACIA B2-MICRO RIA (November 1, 1984)
  • K840213 — BLOOD UREA NITROGEN REAGENT SYS (March 19, 1984)
  • K820418 — K.D. COLORIMETRIC BLOOD UREA N2 TEST (March 11, 1982)
  • K810087 — UREA NITROGEN, KINETIC (February 26, 1981)
  • K792362 — BLOOD UREA NITROGEN REAGENT (December 6, 1979)
  • K770504 — REAGENT SYSTEM (June 27, 1977)