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510(k) K874909

MICRO-BUMINTEST REAGENT TABLETS by Miles Laboratories, Inc. — Product Code JIR

K874909 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "MICRO-BUMINTEST REAGENT TABLETS". The FDA issued a decision of Substantially Equivalent on April 28, 1988. The device falls under product code JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1645. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1988
Date Received
December 1, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1645
Review Panel
CH
Submission Type

Other clearances by Miles Laboratories, Inc.

  • K880605 — LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER (May 26, 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)
  • K864530 — SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. (February 18, 1987)

Other clearances for product code JIR

  • K222921 — Minuteful-kidney test (September 8, 2023)
  • K210069 — Minuteful - kidney test (July 6, 2022)
  • K150330 — Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) (April 30, 2015)
  • K061419 — TECO MICROALBUMIN 2-1 COMBO STRIPS (January 26, 2007)
  • K022538 — IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 (August 23, 2002)
  • K001810 — URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING (August 14, 2000)
  • K994035 — IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 (February 1, 2000)
  • K992257 — NEW MULTIPLES REAGENT STRIPS (November 24, 1999)
  • K991315 — MICROALBUSTIX REAGENT STRIPS (OTC) (November 12, 1999)
  • K983774 — UALB (January 28, 1999)

FDA data resources