AMNIOTEST(TM)— 510(k) K914419

Substantially Equivalent

Pro-Lab, Inc.

FDA 510(k) clearance K914419 for AMNIOTEST(TM), Substantially Equivalent on 1993-09-01. Applicant: Pro-Lab, Inc.. Device class: 1.

Clearance details

Applicant: Pro-Lab, Inc.
Product code: Code HIO
Device class: Class 1
Regulation: 21 CFR 884.1550
Advisory panel: Obstetrics/Gynecology
Date received: 1991-10-03
Decision date: 1993-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario Canada M5m 1c9, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIO

K960203 — G.E. STERILE AMNIOCENTESIS TRAY1996-03-14
K955679 — RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY1996-03-12
K922960 — VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE1992-11-05
K921738 — SONO-VU US(TM), MODIFICATION1992-04-27
K915863 — MEGA AMNIOCENTESIS KIT1992-03-30

More clearances from Pro-Lab, Inc.

K934383 — PROLEX (STREPTOCCAL GROUPING LATEX KIT)1995-01-27
K921421 — LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY1992-07-28
K903714 — E. COLI 0157 LATEX TEST1991-01-24
K894221 — ROSCO PYRR1989-09-28
K883995 — X-ACT UREA/TDA1988-10-12

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