Home / 510(k) Clearances / K780075

510(k) K780075

RIALYZE DIGOXIN by Miles Laboratories, Inc. — Product Code DPG

K780075 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "RIALYZE DIGOXIN". The FDA issued a decision of Substantially Equivalent on February 28, 1978. The device falls under product code DPG (Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.), a Class II device regulated under 21 CFR 862.3300. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1978
Date Received
January 16, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Device Class
Class II
Regulation Number
862.3300
Review Panel
TX
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 DPG

  • K935229 — OPUS DIGITOXIN (December 22, 1993)
  • K812129 — COAT-A-COUNT DIGITOXIN RIA KIT (August 13, 1981)

FDA data resources