MULTICHEM S PLUS / S PLUS (ASSAYED)— 510(k) K132751
Substantially EquivalentTechno-Path Manufacturing , Ltd.
FDA 510(k) clearance K132751 for MULTICHEM S PLUS / S PLUS (ASSAYED), Substantially Equivalent on 2013-10-22. Applicant: Techno-Path Manufacturing , Ltd.. Device class: 1.
Clearance details
- Applicant
- Techno-Path Manufacturing , Ltd.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Highland Village, TX, US
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More clearances from Techno-Path Manufacturing , Ltd.
view allRecalls naming K132751
K-number listed on FDA's recall record- Z-1362-2019 — Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
- Z-1363-2019 — Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132751.
Data sourced from openFDA. This site is unofficial and independent of the FDA.