ENHANCE-S PLUS H— 510(k) K030116

Substantially Equivalent

Conception Technology, Inc.

FDA 510(k) clearance K030116 for ENHANCE-S PLUS H, Substantially Equivalent on 2003-02-12. Applicant: Conception Technology, Inc.. Device class: 2.

Clearance details

Applicant: Conception Technology, Inc.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2003-01-13
Decision date: 2003-02-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQL

K254261 — Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)2026-08-28
K260248 — Ultra-Fast Warm2026-04-28
K252672 — CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)2026-02-20
K250445 — Fast Warm - NX2025-09-12
K251637 — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA] +1 more2025-08-27

More clearances from Conception Technology, Inc.

K030117 — ENHANCE SPERM FREEZE2003-03-20
K991322 — ENHANCE-S PLUS1999-07-26
K991104 — MICROTOOLS1999-07-19
K973860 — OVULON MONITOR1998-01-07

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