ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M— 510(k) K991388

Name: FDA 510(k) clearance K991388
Creator: U.S. Food and Drug Administration
Published: 1999-09-13

Substantially Equivalent

Pacific Andrology, Inc.

FDA 510(k) clearance K991388 for ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M, Substantially Equivalent on 1999-09-13. Applicant: Pacific Andrology, Inc.. Device class: 2.

Clearance details

Applicant: Pacific Andrology, Inc.
Product code: Code MQH
Device class: Class 2
Regulation: 21 CFR 884.6130
Advisory panel: Obstetrics/Gynecology
Date received: 1999-04-21
Decision date: 1999-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQH

view all

K250838 — Denudation Pipettes2025-07-03
K192146 — V-DENUPET2020-01-28
K161275 — EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip2017-01-23
K152581 — LifeGlobal Micro Tips2016-04-11
K151018 — Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette2016-01-08

More clearances from Pacific Andrology, Inc.

view all

K991381 — PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA1999-09-24

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