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510(k) K811342

REAGENT STRIPS FOR URINALYSIS by Miles Laboratories, Inc. — Product Code JRE

K811342 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "REAGENT STRIPS FOR URINALYSIS". The FDA issued a decision of Substantially Equivalent on September 1, 1981. The device falls under product code JRE (Refractometer For Clinical Use), a Class I device regulated under 21 CFR 862.2800. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1981
Date Received
May 12, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Refractometer For Clinical Use
Device Class
Class I
Regulation Number
862.2800
Review Panel
CH
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 JRE

  • K954977 — URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) (March 11, 1996)
  • K941906 — MODEL 2730 CLINICAL REFRACTOMETER (January 17, 1995)
  • K941901 — MODEL 2721 CLINICAL REFRACTOMETER (January 17, 1995)
  • K941903 — MODEL 2740 CLINICAL REFRACTOMETER (January 17, 1995)
  • K941904 — MODEL A300CL CLINICAL REFRACTOMETER (December 13, 1994)
  • K941905 — MODEL 3461 CLINICAL REFRACTOMETER (December 13, 1994)
  • K941902 — MODEL 3471 CLINICAL REFRACTOMETER (December 13, 1994)
  • K891681 — DILECTRON URINARY CONDUCTIVITY PROBE (May 1, 1990)
  • K842168 — ATAGO URINE SPECIFIC GRAVITY & SERUM (July 16, 1984)
  • K831213 — SPECIFIC GRAVITY INSTRUMENT (June 30, 1983)

FDA data resources