HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)— 510(k) K022352
Substantially Equivalent<Genx> Intl., Inc.
FDA 510(k) clearance K022352 for HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS), Substantially Equivalent on 2002-08-28. Applicant: <Genx> Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- <Genx> Intl., Inc.
- Product code
- Code MQL
- Device class
- Class 2
- Regulation
- 21 CFR 884.6180
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guilford, CT, US
Recent devices under product code MQL
view allMore clearances from <Genx> Intl., Inc.
view all- K112083 — LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES
- K092963 — GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3
- K092667 — GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT
- K092578 — LIFEGLOBAL PROTEIN SUPPLEMENT
- K083509 — LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA
Data sourced from openFDA. This site is unofficial and independent of the FDA.