ANDROSTENEDIONE 125I KIT BY RIA— 510(k) K860559

Substantially Equivalent

Immuchem Corp.

FDA 510(k) clearance K860559 for ANDROSTENEDIONE 125I KIT BY RIA, Substantially Equivalent on 1986-03-14. Applicant: Immuchem Corp.. Device class: 1.

Clearance details

Applicant: Immuchem Corp.
Product code: Code CIZ
Device class: Class 1
Regulation: 21 CFR 862.1075
Advisory panel: Clinical Chemistry
Date received: 1986-02-14
Decision date: 1986-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carson, CA, US

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Recent devices under product code CIZ

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K954755 — COAT-A-COUNT DIRECT ANDROSTENEDIONE1995-11-29
K934751 — ACTIVE ANDROSTANEDIOL GLUCURONIDE1994-01-10
K854673 — DSL ANDROSTENEDIONE RIA (DSL # 4200)1986-01-22
K854650 — DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)1985-12-13

More clearances from Immuchem Corp.

K883726 — THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL1988-12-15
K871317 — FOLLICLE STIMULATING HORMONE (HFSH)1987-05-20
K871542 — HPROLACTIN KIT1987-05-14
K865071 — THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT1987-03-13
K864144 — LUTEINIZING HORMONE (LH-IRMA) RIA KIT1986-11-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.