POLYMEDCO OC LIGHT FOBT TEST— 510(k) K041297
Substantially EquivalentPolymedco, Inc.
FDA 510(k) clearance K041297 for POLYMEDCO OC LIGHT FOBT TEST, Substantially Equivalent on 2004-08-12. Applicant: Polymedco, Inc.. Device class: 2.
Clearance details
- Applicant
- Polymedco, Inc.
- Product code
- Code KHE
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cortlandt Manor, NY, US
Recent devices under product code KHE
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- K111143 — POLY-CHEM 90 TOTAL BILIRUBIN
- K100550 — POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
- K090703 — POLY-CHEM 90 GLUCOSE
Recalls naming K041297
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 K041297.
Data sourced from openFDA. This site is unofficial and independent of the FDA.