OVUGEN SURETEST— 510(k) K873534

Substantially Equivalent

Biogenex Laboratories

FDA 510(k) clearance K873534 for OVUGEN SURETEST, Substantially Equivalent on 1987-11-23. Applicant: Biogenex Laboratories. Device class: 1.

Clearance details

Applicant: Biogenex Laboratories
Product code: Product code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1987-09-01
Decision date: 1987-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEP

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K013323 — TCI-31 LIFELONG OVULATION TESTER2001-12-05

More clearances from Biogenex Laboratories

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K925189 — PREGNAGEN 1-STEP PREGNANCY TEST1993-01-06
K902208 — MODIFIED OVUGEN1990-07-17
K884880 — PREGNAGEN(TM)1989-01-13

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