ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION— 510(k) K991341
Substantially EquivalentIrvine Scientific Sales Co., Inc.
FDA 510(k) clearance K991341 for ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION, Substantially Equivalent on 1999-07-08. Applicant: Irvine Scientific Sales Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Irvine Scientific Sales Co., 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
- Santa Ana, CA, US
Recent devices under product code MQL
view allMore clearances from Irvine Scientific Sales Co., Inc.
view allRecalls naming K991341
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991341.
Data sourced from openFDA. This site is unofficial and independent of the FDA.