Home / 510(k) Clearances / K860559

510(k) K860559

ANDROSTENEDIONE 125I KIT BY RIA by Immuchem Corp. — Product Code CIZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1986
Date Received
February 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Androstenedione
Device Class
Class I
Regulation Number
862.1075
Review Panel
CH
Submission Type

Other clearances by Immuchem Corp.

  • K883726 — THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL (December 15, 1988)
  • K871317 — FOLLICLE STIMULATING HORMONE (HFSH) (May 20, 1987)
  • K871542 — HPROLACTIN KIT (May 14, 1987)
  • K865071 — THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT (March 13, 1987)
  • K864144 — LUTEINIZING HORMONE (LH-IRMA) RIA KIT (November 24, 1986)
  • K854094 — IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS (February 28, 1986)
  • K830962 — IMMUCHEM COVALENT-COAT RIA KIT (May 4, 1983)
  • K822509 — COVALENT COAT RIA KIT (September 28, 1982)
  • K822140 — IMMUCHEM COVALENT-COAT (August 5, 1982)
  • K820329 — ESTRADIOL KIT BY RIA (March 4, 1982)

Other clearances for product code CIZ

  • K963002 — ACTIVE ANDROSTENEDIONE EIA (August 16, 1996)
  • K954755 — COAT-A-COUNT DIRECT ANDROSTENEDIONE (November 29, 1995)
  • K934751 — ACTIVE ANDROSTANEDIOL GLUCURONIDE (January 10, 1994)
  • K854673 — DSL ANDROSTENEDIONE RIA (DSL # 4200) (January 22, 1986)
  • K854650 — DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) (December 13, 1985)
  • K844398 — COAT-A-COUNT ANDROSTENEDIONE RIA KIT (December 10, 1984)
  • K842960 — ANDROSTENEDIONE BY RIA (September 27, 1984)
  • K832452 — ANDROSTENEDIONE TEST SET 125I (September 12, 1983)
  • K801729 — ANDROSTENEDIONE RADIOIMMUNOASSAY KIT (October 31, 1980)