PHENYTOIN RIA KIT— 510(k) K770779

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K770779 for PHENYTOIN RIA KIT, Substantially Equivalent on 1977-06-17. Applicant: Amersham Corp.. Device class: 2.

Clearance details

Applicant: Amersham Corp.
Product code: Code DLP
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 1977-04-29
Decision date: 1977-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DLP

K894527 — FPR PHENYTOIN KIT1989-09-25
K811775 — KALLESTAD ANTISERA TO PHENYTOIN1981-07-10
K792640 — FLUOROMATIC PHENYTOIN FIA1980-01-11
K791896 — CENTRIA PHENYTOIN RIA TEST SET1979-10-17

More clearances from Amersham Corp.

K914135 — AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/20861992-02-18
K912733 — AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT1991-07-22
K912766 — AMERLITE CK-MB ASSAY1991-07-17
K904666 — AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/20081990-11-02
K902760 — AMERSHAM TSH CONTROL SERA1990-07-27

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