OVUSTICK SELF-TEST— 510(k) K843284

Substantially Equivalent

Monoclonal Antibodies, Inc.

FDA 510(k) clearance K843284 for OVUSTICK SELF-TEST, Substantially Equivalent on 1984-12-11. Applicant: Monoclonal Antibodies, Inc.. Device class: 1.

Clearance details

Applicant: Monoclonal Antibodies, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1984-08-20
Decision date: 1984-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Monoclonal Antibodies, Inc.

K874863 — RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)1988-02-16
K871726 — OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)1987-07-27
K863744 — HCG CONTROL KIT1986-11-05
K860924 — RAMP PROGESTURINE PDG ASSAY--48 TEST KIT1986-07-02
K854611 — RAMP URINE HCG ASSAY1985-12-30

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