DELFIA (TM) HFSH KIT— 510(k) K862043

Substantially Equivalent

Lkb Instruments, Inc.

FDA 510(k) clearance K862043 for DELFIA (TM) HFSH KIT, Substantially Equivalent on 1986-06-24. Applicant: Lkb Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Lkb Instruments, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1986-05-28
Decision date: 1986-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

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K030058 — EARLYDETECT MENOPAUSE TEST FOR FSH2003-07-30

More clearances from Lkb Instruments, Inc.

K874094 — 1205 BETAPLATE LIQUID SCINTILLATION COUNTER1987-11-04
K872955 — DELFIA(TM) FERRITIN KIT1987-08-21
K871303 — DELFIA(TM) THYROXINE (T4) KIT1987-06-17
K871599 — DELFIA(TM) HIGE KIT1987-06-12
K871644 — DELFIA (TM) HTSH KIT1987-05-12

Recalls naming K862043

K-number listed on FDA's recall record

Z-0779-2017 — DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serumClass III·Terminated·PerkinElmer Health Sciences, Inc.·20161116

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K862043.

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