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510(k) K770659

RIALYZE HPL (RIA) by Miles Laboratories, Inc. — Product Code JMF

K770659 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "RIALYZE HPL (RIA)". The FDA issued a decision of Substantially Equivalent on May 20, 1977. The device falls under product code JMF (Radioimmunoassay, Human Placental Lactogen), a Class II device regulated under 21 CFR 862.1585. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1977
Date Received
April 7, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Human Placental Lactogen
Device Class
Class II
Regulation Number
862.1585
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 JMF

  • K944933 — IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) (March 10, 1995)
  • K840588 — AMERLEX HUMAN PLACENTAL LACTOGEN (April 4, 1984)
  • K823292 — IMMOPHASE TM HPL RADIOIMMUNOASSAY (December 28, 1982)
  • K823201 — HUMAN PLACENTAL LACTOGEN KIT (November 29, 1982)
  • K811370 — NATAL-TEC HPL (May 29, 1981)
  • K802454 — GESTE FOLLOW KIT DETERM. OF HPL (November 12, 1980)
  • K791854 — CENTRIA HPL RIA (October 1, 1979)
  • K790919 — HPL RIA KIT (June 28, 1979)
  • K782099 — RIA TEST, NORDICALB HPL (January 10, 1979)
  • K771656 — PROLACTIN RIA DIAG. KIT (September 22, 1977)

FDA data resources